Orthopedics

Feature Article 

Bupivacaine for Pain Reduction After Iliac Crest Bone Graft Harvest

Dennis T. Lockney, MD; Jesse E. Bible, MD, MHS; Colin G. Crosby, MD; Clinton J. Devin, MD

Abstract

Iliac crest bone graft remains the gold standard in achieving spinal arthrodesis, but chronic pain from graft harvest occurs in up to 39% of patients. Studies have shown that a single administration of local anesthetic reduces short-term pain, but they have not adequately investigated possible longer-term benefits. The goal of this study was to determine whether local administration of bupivacaine after iliac crest bone graft harvesting reduces pain and improves patient-reported outcomes. In this prospective, randomized, controlled, and blinded clinical study, 40 patients were identified who underwent posterior spine fusion with iliac crest bone graft and were randomized to receive either bupivacaine (treatment group, n=20) or saline (control group, n=20) at the iliac crest bone graft site. Pain at the harvest site was determined by a series of 12 visual and numeric pain scale assessments. Short Form-12 mental and physical component scores, EuroQol-5D, and Oswestry Disability Index assessments were made, along with determination of patient satisfaction and self-reported outcome of surgery. Baseline pain and outcome assessments were statistically similar (P>.05). Average pain scores were lower for all 12 assessments in the treatment group at mean follow-up of 5 weeks (significant differences in 6 assessments) and 20 weeks (significant differences in 2 assessments). No significant differences were found in Short Form-12 and EuroQol-5D scores. For patients who underwent lumbar fusion, the treatment group had significantly improved Oswestry Disability Index scores (mean±SD=10.8±7.1 vs 18.7±5.9, P=.012). Significantly more patients in the treatment group reported that surgery met all expectations (90% vs 50%, P=.016). This study is the 1st to show that a single administration of bupivacaine at the iliac crest bone graft harvest site during posterior spine fusion surgery can result in improved outcomes and reduced pain far beyond the anesthetic duration of activity.

The authors are from the Department of Orthopaedics (KRO, JEB, CGC, CJD), Vanderbilt University Medical Center; and the Department of Orthopaedics (DTL), Vanderbilt University School of Medicine, Nashville, Tennessee.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Jesse E. Bible, MD, MHS, Department of Orthopaedics, Vanderbilt University Medical Center, Medical Center East, South Tower, Ste 4200, 1215 21st Ave S, Nashville, TN 37232 ( jesse.bible@vanderbilt.edu).

Received: May 16, 2013
Accepted: November 08, 2013

Abstract

Iliac crest bone graft remains the gold standard in achieving spinal arthrodesis, but chronic pain from graft harvest occurs in up to 39% of patients. Studies have shown that a single administration of local anesthetic reduces short-term pain, but they have not adequately investigated possible longer-term benefits. The goal of this study was to determine whether local administration of bupivacaine after iliac crest bone graft harvesting reduces pain and improves patient-reported outcomes. In this prospective, randomized, controlled, and blinded clinical study, 40 patients were identified who underwent posterior spine fusion with iliac crest bone graft and were randomized to receive either bupivacaine (treatment group, n=20) or saline (control group, n=20) at the iliac crest bone graft site. Pain at the harvest site was determined by a series of 12 visual and numeric pain scale assessments. Short Form-12 mental and physical component scores, EuroQol-5D, and Oswestry Disability Index assessments were made, along with determination of patient satisfaction and self-reported outcome of surgery. Baseline pain and outcome assessments were statistically similar (P>.05). Average pain scores were lower for all 12 assessments in the treatment group at mean follow-up of 5 weeks (significant differences in 6 assessments) and 20 weeks (significant differences in 2 assessments). No significant differences were found in Short Form-12 and EuroQol-5D scores. For patients who underwent lumbar fusion, the treatment group had significantly improved Oswestry Disability Index scores (mean±SD=10.8±7.1 vs 18.7±5.9, P=.012). Significantly more patients in the treatment group reported that surgery met all expectations (90% vs 50%, P=.016). This study is the 1st to show that a single administration of bupivacaine at the iliac crest bone graft harvest site during posterior spine fusion surgery can result in improved outcomes and reduced pain far beyond the anesthetic duration of activity.

The authors are from the Department of Orthopaedics (KRO, JEB, CGC, CJD), Vanderbilt University Medical Center; and the Department of Orthopaedics (DTL), Vanderbilt University School of Medicine, Nashville, Tennessee.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Jesse E. Bible, MD, MHS, Department of Orthopaedics, Vanderbilt University Medical Center, Medical Center East, South Tower, Ste 4200, 1215 21st Ave S, Nashville, TN 37232 ( jesse.bible@vanderbilt.edu).

Received: May 16, 2013
Accepted: November 08, 2013

The use of autograft bone remains the gold standard in achieving segmental fusion in spinal surgery, with iliac crest bone graft the most common source.1 Iliac crest bone graft provides osteoconductive, osteoinductive, and nonimmunogenic bone without the risk of disease transmission.2–5 However, donor site morbidity remains a significant concern.6–9 Although more serious complications have been described in case reports, pain remains the most frequent morbidity.6,10–15 Short-term pain has been reported in 69% to 87% of patients, and estimates of chronic pain after iliac crest bone graft have ranged from 10% to 39%.3,6,16 Previous studies have shown that administration of a local anesthetic at the iliac crest bone graft harvest site may be a simple means of decreasing short-term pain and preventing chronic pain.2,16–28

Most previous studies have investigated the use of an indwelling catheter left in place at the time of surgery to deliver a local anesthetic at the iliac crest bone graft site. Although some studies did not demonstrate a significant effect,22,23,26 others have shown this method to be efficacious in reducing postoperative pain and preventing chronic pain.2,18,19,25 However, the drawbacks to catheter use include a possible increased risk of infection22,23 and high cost.26 As a result, a single administration of local anesthetic at the time of surgery, rather than via an indwelling catheter, has been investigated. Using this simpler technique, studies have shown improved early postoperative pain, earlier ambulation and return to normal activity, and reduced narcotic usage compared with control groups.20,21,24,27

Until recently, no study had investigated whether this technique could also help to reduce postoperative pain beyond the short term, as had been shown in earlier studies with an indwelling catheter. In a study of patients undergoing facial reconstructive surgery with anterior iliac crest bone graft, no difference in visual analog pain scores was found at any early postoperative time point or after a minimum of 1-year follow-up.17 However, the study relied on a mail survey for long-term follow-up and had very low follow-up rates that complicated interpretation of the results, with only 49% of patients completing early follow-up and 29% completing long-term follow-up. Given these shortcomings, the question of whether a single application of local anesthetic can help to prevent pain at later time points remains unanswered.

The goal of this study was to investigate whether a single administration of bupivacaine within the iliac crest bone graft harvest site would decrease pain after spine surgery at time points well beyond the anesthetic duration of activity. No previous study has investigated this question in the spine using posterior iliac crest bone graft. The hypothesis was that the use of bupivacaine would result in significantly decreased pain.

Materials and Methods

A prospective, randomized, placebo-controlled, and blinded study was developed with institutional review board approval. The study was conducted at a single academic institution from September 2010 through October 2011. All patients aged more than 18 years who were undergoing posterior spinal fusion with posterior iliac crest bone graft were considered eligible for inclusion. All patients had failed conservative management of their symptoms associated with either cervical or lumbar pathology. Additional inclusion criteria were: (1) English speaking, (2) able to give written consent, and (3) willing to participate in answering questionnaires. Exclusion criteria included: (1) previous iliac crest bone graft harvest, (2) receipt of workers’ compensation, (3) ongoing litigation, (4) pregnancy, and (5) known allergy to any local anesthetic.

Randomization

A block randomization scheme was used to assign patients to either a treatment group receiving bupivacaine or a control group receiving normal saline at the iliac crest bone graft site during surgery. The senior author (C.J.D.) enrolled all patients in the preoperative holding area. Written consent was obtained from all patients. On enrollment, a sealed envelope containing the group assignment was opened and the appropriate intervention was performed. Patients were not informed of their assigned group at any point during the study.

Surgical Technique

The senior author (C.J.D.) oversaw posterior iliac crest bone graft harvesting in the same manner for each patient. An oblique incision was made directly over the posterior superior iliac spine, and electrocautery was used to dissect down to the cortical bone. A rectangular window of approximately 4×1 cm was created in the cortex of the posterior superior iliac spine using osteotomes and was then hinged open to allow access to cancellous bone. Care was taken not to violate cortical bone. After graft harvest, the cavity was packed with gel foam that had been soaked in either 10 mL 0.25% bupivacaine (Hospira, Inc, Lake Forest, Illinois), if assigned to the treatment group, or 10 mL 0.9% normal saline, if assigned to the control group. The cortical bone window was replaced, and layered closure was performed in the usual manner. No drain was used for the iliac crest bone graft harvest site.

Patient Characteristics

Demographic information (age, sex, marital status), employment status and type (or reason for unemployment if not employed), medical history (diabetes, lung disease or asthma, kidney disease, thyroid disease, liver disease, heart disease, hypertension, cancer, seizure disorder, arthritis), history of tobacco and alcohol use (including screening for signs of alcoholism), and psychiatric history (medication usage, depression, anxiety, bipolar disorder, schizophrenia) were obtained at the time of study enrollment. History of narcotic (prescription opioids) usage was also determined.

Surgical Data

Surgical data collected included the type of surgery, the surgical indication, whether the surgery was a revision, the number of levels fused, the use of instrumentation, operative time, and estimated blood loss. Complications at the iliac crest bone graft harvest site, including infection, were assessed at the time of discharge and at subsequent postoperative visits. The length of hospitalization was also recorded.

Pain Assessments

Assessments were made at the time of study enrollment, at the first follow-up appointment (approximately 4 to 6 weeks), and at the subsequent follow-up appointment (approximately 4 to 6 months). Patients were asked specifically to answer only regarding pain at the proposed iliac crest bone graft harvest site preoperatively and at the actual surgical site postoperatively. All forms were administered and collected by a research nurse without knowledge of the assigned group. Patients completed a visual analog pain score by marking on a 10-cm line their pain level at the time of evaluation at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement. An investigator, also blinded to the treatment group, converted the markings to numeric scores (range, 0–10 each). Patients also completed a numeric rating scale to indicate their worst and least pain levels in the past 24 hours, pain on average, and current pain (range, 0–10 each). Cumulative visual analog pain score and numeric rating scale scores were calculated using the sum of these scores (range, 0–60 for visual analog pain score; range, 0–40 for numeric rating scale).

Health Quality and Functional Outcomes

Additional patient outcomes were prospectively assessed preoperatively and approximately 4 to 6 months postoperatively via telephone interview by an independent research nurse who was blinded to the study groups. Patients completed the Short Form-12 mental and physical component scores, a numeric rating scale for neck or back pain, and a preference-based health state utility score from the EuroQol Group. Patients undergoing lumbar surgery also completed the Oswestry Disability Index, a validated outcome measure scored on a scale of 0 to 50 in which higher scores indicate higher back-related disability.29

Final Outcome Assessments

Patient satisfaction was determined by asking patients to indicate whether they were: (1) extremely satisfied, (2) somewhat satisfied, (3) neither satisfied nor dis-satisfied, (4) somewhat dissatisfied, or (5) extremely dissatisfied. Patient-assessed outcome was determined by having patients respond with one of the following options: (1) surgery met all expectations; (2) symptoms improved and patient would have surgery again; (3) symptoms improved, but patient would not have surgery again; (4) symptoms are the same or worse than before. Finally, patients were asked whether they had returned to work.

Statistics

Sample size estimation was performed and showed a minimally clinically important difference in visual analog pain scores of 230 and expected standard deviation of visual analog pain scores of 224 (α=0.05%; β=0.80). This analysis indicated that 17 patients would need to be included in each group (PS Power, http://biostat.mc.vanderbilt.edu/PowerSampleSize). Comparisons between treatment groups were made using Fisher’s exact tests for binary nominal responses, chi-square tests for multidimensional nominal responses, and Mann-Whitney tests for continuous variables. All statistical tests were performed using Prism (GraphPad Software, Inc, La Jolla, California). Significance was set at .05. Data are presented as mean±standard deviation unless otherwise noted.

Results

Baseline Characteristics

Twenty patients were enrolled in each group. All 20 patients in the treatment group completed the first follow-up evaluation, and 19 completed the final evaluation. In the control group, 19 completed the follow-up evaluation and 17 completed the final evaluation. All patients completed either the follow-up evaluation or the final evaluation. Groups were similar with regard to demographics, comorbidities, and history of substance abuse. A higher number of patients in the control group reported daily narcotic use compared with the treatment group, but an equal number of patients in each group reported chronic pain (Table 1). All baseline outcome measures were statistically similar between the groups preoperatively.

Baseline Characteristics of Treatment and Control Groups

Table 1:

Baseline Characteristics of Treatment and Control Groups

Operative Data

Surgical variables were also statistically similar between the groups (Table 2). A higher number of patients underwent revision in the treatment group than in the control group, but this difference did not reach statistical significance (P=.40). No complications were noted in the treatment group, but 1 superficial infection occurred in the control group. The length of stay was found to be statistically similar (treatment group, 4.0±1.2; control group, 4.7±1.8).

Surgical Variables of Treatment and Control Groups

Table 2:

Surgical Variables of Treatment and Control Groups

Pain Assessments

The time to the first follow-up evaluation was similar in the treatment (4.9±0.8 weeks; median, 4.7 weeks) and control groups (5±1.2 weeks; median, 4.7 weeks). No significant difference in the percentage of patients using narcotics was found (45% in the treatment group vs 70% in the control group). Patients in the treatment group reported significantly lower visual analog pain scores for current pain at rest (P=.042) (Figure 1). The cumulative visual analog pain score was significantly lower in the treatment group (10.5±11 vs 21.7±17, P=.036). For numeric rating scale scores (Figure 2), the treatment group had significantly lower worst (P=.027), average (P=.031), and current pain scores (P=.008). The cumulative numeric rating scale score was also significantly lower in the treatment group (6±6.4 vs 13.1±9.9, P=.017).

Visual analog pain (VAS) scores in the treatment group receiving bupivacaine and the control group receiving saline at the iliac crest bone graft harvest site at initial (mean, 5 weeks) and final follow-up (mean, 20 weeks). Abbreviations: AAR, average pain at rest; AWM, average pain with movement; PAR, pain at rest; PWM, pain with movement; WAR, worst pain at rest; WWM, worst pain with movement. *Statistically significant difference between treatment groups (P<.05).

Figure 1:

Visual analog pain (VAS) scores in the treatment group receiving bupivacaine and the control group receiving saline at the iliac crest bone graft harvest site at initial (mean, 5 weeks) and final follow-up (mean, 20 weeks). Abbreviations: AAR, average pain at rest; AWM, average pain with movement; PAR, pain at rest; PWM, pain with movement; WAR, worst pain at rest; WWM, worst pain with movement. *Statistically significant difference between treatment groups (P<.05).

Numeric rating pain scale (NRS) scores in the treatment group receiving bupivacaine and the control group receiving saline at the iliac crest bone graft harvest site at initial (mean, 5 weeks) and final follow-up (mean, 20 weeks). *Statistically significant difference between treatment groups (P<.05).

Figure 2:

Numeric rating pain scale (NRS) scores in the treatment group receiving bupivacaine and the control group receiving saline at the iliac crest bone graft harvest site at initial (mean, 5 weeks) and final follow-up (mean, 20 weeks). *Statistically significant difference between treatment groups (P<.05).

The second follow-up time was also similar between groups (treatment group: 20.1±6 weeks; median, 18.6 weeks; control group: 18.7±4.7 weeks; median, 17.7 weeks). Again, no significant difference in the percentage of patients using narcotics was found (5% in the treatment group vs 18% in the control group). The treatment group had significantly lower visual analog pain scores for current pain at rest (P=.046) and average pain at rest (P=.026). No significant differences were found in the numeric rating scale assessments.

Health Quality and Functional Outcomes

Telephone interviews with patients were conducted at statistically similar times postoperatively in the treatment (17.6±9.6 weeks; median, 15.4 weeks) and control groups (22.9±13 weeks; median, 18.4 weeks). Assessments were available for 18 treatment subjects and 14 control subjects. No significant differences between Short Form-12 mental component score (treatment group, 50.9±9.8; control group, 47.3±10.2) and physical component score (treatment group, 43.2±8.5; control group, 38.6±10.8) were found between groups. Numeric rating scale scores for neck or back pain were also similar (treatment group, 2.7±2.7; control group, 3.6±3.2). Health state utility EuroQol-5D scores were higher in the treatment group (0.81±0.11) compared with the control group (0.72±0.19), but the difference did not reach significance (P=.143). However, Oswestry Disability Index scores in patients who had lumbar spine fusion were significantly lower in the treatment group (10.8±7.1) compared with the control group (18.7±5.9, P=.012), indicating less back-related disability in those treated with bupivacaine.

Final Outcome Assessments

A strong trend was found toward increased patient-reported satisfaction and improved self-assessed outcome in the treatment group, but the difference did not reach significance (Table 3). However, a significantly higher number of patients in the treatment group reported that surgery met all expectations (P=.016).

Final Outcome Parameters

Table 3:

Final Outcome Parameters

Discussion

The goal of this study was to evaluate whether a single intraoperative administration of bupivacaine would result in decreased pain at the site of posterior iliac crest bone graft harvesting after spine fusion surgery. The group of patients who received bupivacaine reported decreased pain well beyond the expected anesthetic duration of activity. In a subset analysis, patients undergoing lumbar fusion reported significantly improved Oswestry Disability Index scores if bupivacaine was administered. Further, these patients more often reported that the overall surgical experience met their expectations. This is the first study to show that a single application of bupivacaine at the iliac crest bone graft harvest site can help to decrease associated pain and potentially improve outcomes.

Previous studies evaluated the use of local anesthetics at the iliac crest bone graft harvest site. The immediate postoperative and short-term benefits of a single administration of local anesthetic to the iliac crest bone graft harvest site are well established. Todd and Reed27 first reported this technique in 1991 and showed decreased immediate postoperative pain at the iliac crest bone graft harvest site in patients undergoing extremity surgery. A later study by Hoard et al21 showed that applying local anesthetic to the iliac crest bone graft site allowed earlier ambulation and faster return to normal activity in children undergoing cleft palate surgery. Finally, Schaan et al24 showed that narcotic use decreased and iliac crest bone graft donor site visual analog pain scores were lower until 5 days postoperatively in patients who received local anesthetic after cervical fusion.

However, the longer-term results of this technique have not been adequately investigated. Most previous studies investigating local anesthetic at the iliac crest bone graft harvest site have used an indwelling catheter to deliver the anesthetic agent, either by continuous infusion or by intermittent bolus. These studies have shown reduced pain after as many as 4 years postoperatively.2,19,25 The question was therefore posed as to whether similar results could be achieved using a more practical one-time administration of local anesthetic at the time of surgery. Before this investigation, only 1 study had evaluated possible longer-term results using this technique, and no difference compared with a control group was found.17 However, methodologic flaws and a follow-up rate of less than 50% limited the accuracy of this study. In contrast, the results of the current study showed significantly lower pain scores at early (mean, 5 weeks) and later (mean, 20 weeks) follow-up. Therefore, in addition to the possible short-term benefits previously shown, it seems that a single application of local anesthetic can reduce longer-term pain at the iliac crest bone graft site without the added cost and risk of infection associated with the use of an indwelling catheter.

Pain reduction beyond the anesthetic duration of activity, termed preemptive analgesia, has been investigated previously. This has been defined as an anti-nociceptive treatment that prevents establishment of altered central processing of afferent input from sites of injury.31,32 As pointed out by Kelly et al,31,32 preemptive analgesia requires multimodal agents and depends on the timing of administration as well as patient characteristics. The use of local anesthetics is 1 method to potentially prevent long-term pain. Local anesthetics may reduce transmission of the noxious afferent input resulting from surgery to the central nervous system and thereby minimize the sensitization and hyperexcitability that may otherwise occur.33–35 Further, local anesthetics have been found to diminish local inflammation after surgery, which may help to reduce the sensitization of nociceptive receptors and therefore decrease chronic pain.36

There were limitations to this study. Similar to many studies using pain assessments, there were confounding factors that were uncontrolled for in this analysis. Randomization eliminated selection bias, but the results must still be weighed against the possible effect of unbalanced variables. For instance, higher baseline narcotic use and operative time may favor higher pain scores in the control group, whereas a higher number of revisions might be expected to result in higher scores in the treatment group. An important confounding variable to consider is referred pain. Patients have difficulty distinguishing iliac crest bone graft pain from low back pain,37 and patients report higher iliac crest bone graft pain scores after primary lumbar surgery compared with more cephalad surgery.5 In this study, it was not possible to determine the true breakdown of pain caused by the iliac crest bone graft harvest site vs referred pain, and the authors instead reported only what patients perceived as pain attributable to the iliac crest bone graft site. Importantly, baseline preoperative outcome assessments were statistically similar between groups. As with the pain assessments, confounding factors may have contributed to observed differences in health state utility and functional outcome measures. Specifically, this study did not formally standardize the surgeries performed or rigidly evaluate the primary operative indications. As a result, differences in such outcome measures may be affected by uncontrolled factors. Finally, some patients were lost to follow-up. Nevertheless, the authors achieved 98% initial follow-up and 85% final follow-up and met the goal of 17 patients per group as determined from the sample size calculation.

Conclusion

This study showed that a single application of bupivacaine within the iliac crest bone graft harvest site at the time of surgery reduced pain scores far beyond the anesthetic duration of activity. Although previous studies showed important short-term benefits of this practice, this study is the first to show the potential for long-term pain reduction. No complications were associated with this technique. Therefore, a single administration of bupivacaine was found to be a safe and effective means of decreasing pain associated with iliac crest bone graft harvest during spine surgery.

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Baseline Characteristics of Treatment and Control Groups

Characteristic Bupivacaine Group Saline Group

N % N %
Mean±SD age, y 66±12 62±8
Male 13 65 13 65
Marital status
  Single 1 5 2 10
  Married 12 60 10 50
  Widowed 4 20 2 10
  Divorced 2 10 5 25
  Separated 1 5 0 0
Education level
  <12th grade 2 10 3 15
  12th grade 5 25 6 30
  Some college 2 10 5 25
  College degree 8 40 6 30
  Graduate degree 3 15 0 0
Employed 9 45 6 30
Reason for unemployment
  Retired 8 40 3 15
  Disabled 3 15 11 55
Number of comorbidities (mean±SD) 2.0±1.4 2.4±1.6
  Tobacco use 18 90 16 80
  Alcohol use 7 35 6 30
Positive CAGE screen 1 5 0 0
  Chronic pain 19 95 19 95
  Daily narcotic use 3 15 12 60

Surgical Variables of Treatment and Control Groups

Characteristic Bupivacaine Group Saline Group

N % N %
Indication
  Stenosis 17 85 17 85
  Spondylolisthesis 15 75 15 75
  Adjacent segment disease 1 5 0 0
  Disk herniation 2 10 1 5
  Pseudarthrosis 1 5 3 15
Primary surgery
  Laminectomy 20 100 19 95
  Transforaminal lumbar interbody fusion 10 50 6 30
Revision 6 30 3 15
Region
  Cervical 2 10 4 20
  Lumbar 18 90 16 80
Instrumentation 17 85 18 90
Levels fused 1.6±1.0 2.2±1.7
Estimated blood loss (mean±SD), mL 489±232 546±307
Operative time (mean±SD), min 236±52 264±73
Complication
  Infection 0 0 1 5

Final Outcome Parameters

Characteristic Bupivacaine Group Saline Group

N % N %
Employment
  Preoperatively employed 9 45 6 30
  Postoperatively employed 7 35 2 10
Outcome
  Met expectations 18 90 10 50
  Improved, would undergo again 0 0 2 10
  Improved, would not undergo again 1 5 4 20
  Same or worse than preoperatively 0 0 1 5
Satisfaction
  Very satisfied 15 75 9 45
  Somewhat satisfied 3 15 6 30
  Neither 0 0 1 5
  Somewhat dissatisfied 1 5 0 0
  Very dissatisfied 0 0 1 5

10.3928/01477447-20140430-52

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