Orthopedics

Feature Article 

Reduced Opioid Use Among Patients Who Received Liposomal Bupivacaine for ACL Reconstruction

Brandon T. Stryder, MS; Paulina M. Szakiel, MS; Michael Kelly, MD; Henry T. Shu, BS; Blake M. Bodendorfer, MD; Stephen Luck, MD; Evan H. Argintar, MD

Abstract

Standard multimodal pain management for anterior cruciate ligament reconstruction typically includes a combination of local anesthetics, nonsteroidal anti-inflammatory drugs, and opioids. Opioids present a substantial risk, and there is a rising number of prescription opioid-related overdoses in the United States. The goal of this study was to evaluate the quantity of opioids prescribed to patients who received liposomal bupivacaine as a component of their multi-modal pain regimen. The electronic medical records of patients who underwent anterior cruciate ligament reconstruction by a single surgeon at an urban hospital during a 2-year period were evaluated. Patients in the case group received liposomal bupivacaine and those in the control group did not. Statistical analysis of the number of pills prescribed and numeric pain rating scale scores was performed with a 2-tailed unequal variance t test. Statistical analysis of opioid prescription refills was performed with a chi-square test. A total of 67 patients were included. The mean number of 5-mg oxycodone tablets prescribed to the case group (9.29±10.29 tablets) was significantly lower (P<.01) compared with the number prescribed to the control group (66.26±37.13 tablets). Patients in the case group also were less likely to require an opioid prescription refill at the first follow-up appointment (P<.01; absolute risk reduction, 50%; number needed to treat, 2). Mean numeric pain rating scale score at 2 weeks was 2.8±2.1 in the case group and 3.8±2.4 in the control group (P=.09). Patients who received liposomal bupivacaine as part of multimodal pain management had significantly fewer opioid prescriptions. Despite the reduction in opioids prescribed, patients in the case group only showed a trend toward a reduction in pain at 2-week follow-up. [Orthopedics. 2021;44(x):xx–xx.]

Abstract

Standard multimodal pain management for anterior cruciate ligament reconstruction typically includes a combination of local anesthetics, nonsteroidal anti-inflammatory drugs, and opioids. Opioids present a substantial risk, and there is a rising number of prescription opioid-related overdoses in the United States. The goal of this study was to evaluate the quantity of opioids prescribed to patients who received liposomal bupivacaine as a component of their multi-modal pain regimen. The electronic medical records of patients who underwent anterior cruciate ligament reconstruction by a single surgeon at an urban hospital during a 2-year period were evaluated. Patients in the case group received liposomal bupivacaine and those in the control group did not. Statistical analysis of the number of pills prescribed and numeric pain rating scale scores was performed with a 2-tailed unequal variance t test. Statistical analysis of opioid prescription refills was performed with a chi-square test. A total of 67 patients were included. The mean number of 5-mg oxycodone tablets prescribed to the case group (9.29±10.29 tablets) was significantly lower (P<.01) compared with the number prescribed to the control group (66.26±37.13 tablets). Patients in the case group also were less likely to require an opioid prescription refill at the first follow-up appointment (P<.01; absolute risk reduction, 50%; number needed to treat, 2). Mean numeric pain rating scale score at 2 weeks was 2.8±2.1 in the case group and 3.8±2.4 in the control group (P=.09). Patients who received liposomal bupivacaine as part of multimodal pain management had significantly fewer opioid prescriptions. Despite the reduction in opioids prescribed, patients in the case group only showed a trend toward a reduction in pain at 2-week follow-up. [Orthopedics. 2021;44(x):xx–xx.]

Anterior cruciate ligament (ACL) reconstruction surgery is among the most commonly performed orthopedic procedures, with an estimated incidence rate of 74.6 per 100,000 individuals in 2014.1–3 Postoperative pain management for patients who undergo ACL reconstruction is an important consideration to expedite recovery time, maximize patient satisfaction, and help patients to return to normal activity.4–6 The American Pain Society recommends a multimodal approach to pain management that varies based on the procedure, patient, and setting.6 Typical multimodal pain management for ACL reconstruction uses a combination of local anesthetics, oral nonsteroidal anti-inflammatory drugs (NSAIDs), and intravenous or oral opioids.7 Opioids are highly addictive and can cause respiratory depression in large doses.8 Moreover, the number of prescription opioid overdoses in the United States has increased by a factor of 4 during the past 15 years.9–11 Common side effects of narcotic use include nausea, constipation, drowsiness, and confusion, all of which contribute to postoperative discomfort and dissatisfaction. As a result, surgeons and health care providers have been encouraged to pursue nonopioid pain management options when possible.

Orthopedic surgeons are the third highest prescribers of opioids among physicians in the United States and the highest among all surgical specialties.12–14 This finding can be explained in part by the nature of orthopedic procedures, which are often invasive and involve significant disruption of native tissue. Nonetheless, opioids are often prescribed excessively after orthopedic procedures. In a pediatric population undergoing ACL reconstruction, approximately 36% of prescribed opioids were used and only 35% of patients and their families knew how to dispose of unused pain medications properly.15 Similarly, Sabatino et al16 found that 61% of patients reported having unused opioids and only 41% of patients reported appropriate disposal of unused opioid pills. Unused opioids pose a risk for opioid abuse because an estimated 70% of those abusing opioids obtained their opioids from unused prescriptions from family and friends.17–19 Although chronic opioid use can be defined in a variety of ways, multiple studies have shown that preoperative opioid use, a history of substance abuse, a history of mental illness, and health-seeking behavior are risk factors for chronic opioid use in surgical patients.20–25

Given the burden of opioid addiction in the United States and the role of orthopedic surgeons in prescribing opioids, the authors sought to examine the use of an opioid-free pain management protocol with liposomal bupivacaine (Exparel; Pacira) after ACL reconstruction at their institution. Exparel is the only extended-release bupivacaine formulation approved by the US Food and Drug Administration for use as a local anesthetic during surgery.9 Randomized controlled trials of total knee arthroplasty, bunionectomy, submuscular augmentation mammoplasty, and hemorrhoidectomy showed that liposomal bupivacaine produced long-lasting analgesic effects without opioid-related side effects, making it an effective tool for postoperative pain management.26 However, the use of liposomal bupivacaine in ACL reconstruction is still controversial because of its high cost and conflicting findings on its effectiveness compared with bupivacaine hydrochloride and peripheral nerve block alone.27,28 Thus, more information on liposomal bupivacaine is needed to justify its use.

The goal of this study was to compare the total opioids prescribed, opioid prescription refills, and numeric pain rating scale (NPRS) scores during the first postoperative follow-up visit of patients who received a multimodal pain management protocol with liposomal bupivacaine and a multimodal pain management protocol with a peripheral nerve block.

Materials and Methods

Study Population

After institutional review board approval was obtained, the authors retrospectively reviewed all ACL reconstructions performed by a single fellowship-trained and board-certified sports medicine senior orthopedic surgeon (E.H.A.) between January 2017 and April 2019 at an urban level I trauma center. Electronic medical records were accessed and patient information was recorded from the hospital database with a secured document. All patients who underwent ACL reconstruction were identified by searching the hospital database with Current Procedural Terminology code 29888.

With these results, the electronic medical records of 118 patients were evaluated for other medical conditions that may have increased the need for additional pain management therapy. In total, 51 patients were excluded based on the criteria shown in Table 1.

Exclusion Criteria

Table 1:

Exclusion Criteria

After the exclusion criteria were applied, 67 patients were eligible for further analysis. Information on patient history, demographic features, operative information, and postoperative follow-up was recorded. Factors of interest included age, sex, documented opioid use up to 3 months before surgery, concurrent procedures (meniscal repair or meniscectomy), nerve block use, liposomal bupivacaine use, opioid prescription on the day of surgery, NSAID prescription on the day of surgery, opioids prescribed at the first follow-up visit, NSAIDs prescribed at the first follow-up visit, NPRS score during the first follow-up visit, and postoperative complications.

Surgical Technique

All patients were examined under anesthesia in the operating room. All patients had positive preoperative pivot shift and Lachman examinations. Each patient was prepared and draped in the standard sterile fashion with the use of a tourniquet. After the respective grafts were harvested and implanted, examination under anesthesia was performed to test range of motion, varus/valgus stability, anterior/posterior drawer, and pivot shift. All patients had normalized anterior drawer and pivot shift examinations postoperatively.

Graft types used are shown in Table 2, and concurrent procedures, such as meniscal repair, meniscectomy, or chondroplasty, are shown in Table 3.

Graft Type Used for Anterior Cruciate Ligament Reconstruction

Table 2:

Graft Type Used for Anterior Cruciate Ligament Reconstruction

Type of Surgery Performed

Table 3:

Type of Surgery Performed

Pain Management Protocol

Of the 67 patients who were included in the study, 17 underwent the opioid-sparing multimodal pain management protocol. All patients underwent preoperative ultrasound-guided femoral nerve block performed by a fellowship-trained and board-certified anesthesiologist (S.L.).

Patients in the control group received a catheter-based peripheral nerve block that remained in place for 2 days. Postoperative care included a prescription for 200 mg celecoxib to be taken twice a day for 2 weeks, then as needed for pain, and a standard prescription quantity of 60 tablets of an opioid/NSAID combination (5 mg oxycodone, 325 mg acetaminophen) to be taken as needed for pain.

The case group received ultrasound-guided preoperative liposomal bupiva-caine subcutaneous field block injections and intraoperative diluted liposomal bupivacaine subcutaneous injections. The technique, dose, and total volume of liposomal bupivacaine used in surgery for the case group were based on the recommendation from a case report by Sigman.29 Each patient in the case group received a solution of 20 mL liposomal bupivacaine (266 mg), 20 mL bupivacaine hydrochlo-ride 0.25%, and 40 mL normal saline, for a total of 80 mL. Postoperative care included a prescription for 200 mg celecoxib to be taken twice a day for 2 weeks, 40 tablets of acetaminophen 500 mg as needed for pain, and 5 tablets of oxyco-done 5 mg as needed for pain.

Patients in both the control and case groups were told to limit their consumption of narcotics as much as possible. Patients in the case group were informed that they would receive liposomal bupivacaine to reduce the amount of postoperative pain.

Statistical Analysis

The primary outcome for this study was the quantity of opioids prescribed after the procedure. These values were recorded as the number of tablets of oxycodone 5 mg and the oral morphine milligram equivalent (MME) for additional statistical analysis.

Statistical analysis was performed with JMP Pro software, version 14 (SAS Institute, Inc). A 2-sample F test was conducted to determine variance between groups, followed by a 2-tailed unequal variance t test.

Secondary outcomes included the need for refill of pain medication at the first follow-up visit and self-reported NPRS scores. These data were analyzed with a chi-square test to assess significance. Statistical significance was assigned at P<.05. Post hoc power analysis was conducted to evaluate nonsignificant results.

Results

A total of 67 participants were included in the study, with 17 patients in the case group and 50 in the control group. No significant differences between the case and control groups were noted for demographic features or the time between surgery and the first follow-up appointment. Mean age was 29.82±8.77 years in the case group and 32.46±8.76 years in the control group (P=.29). The case group included 4 women and 13 men, and the control group included 17 women and 33 men (P=.41). Mean time between surgery and the first follow-up appointment was 14.13±3.31 days in the case group and 13.54±3.31 days in the control group (P=.60).

Postoperative Opioid Prescriptions

A significant difference was noted between the mean number of oxycodone tablets prescribed to the case and control groups (P<.0001), with 9.29±10.29 tablets and 66.26±37.13 tablets prescribed, respectively (Figure 1). A significant difference also was found between the mean number of oxycodone tablets refilled for the case and control groups at the first follow-up visit (P=.0001), with 2.35±9.70 and 20.20±21.99 tablets refilled, respectively (Figure 2).

Mean number of tablets of oxycodone 5 mg prescribed to patients after anterior cruciate ligament reconstruction.

Figure 1:

Mean number of tablets of oxycodone 5 mg prescribed to patients after anterior cruciate ligament reconstruction.

Mean number of tablets of oxycodone 5 mg prescribed to patients at the first follow-up visit after anterior cruciate ligament reconstruction.

Figure 2:

Mean number of tablets of oxycodone 5 mg prescribed to patients at the first follow-up visit after anterior cruciate ligament reconstruction.

The quantity of opioids prescribed was converted to MME according to the Centers for Disease Control and Prevention guidelines.13 Mean numbers of MME prescribed to the case and control groups were 69.71±77.21 and 532.24±275.19, respectively (P<.0001) (Figure 3). Mean numbers of MME refilled at the first follow-up visit were 17.64±72.76 and 164.50±165.99 for the case and control groups, respectively (P<.0001) (Figure 4).

Mean number of morphine milligram equivalents prescribed to patients after anterior cruciate ligament reconstruction.

Figure 3:

Mean number of morphine milligram equivalents prescribed to patients after anterior cruciate ligament reconstruction.

Mean number of morphine milligram equivalents prescribed to patients at the first follow-up visit after anterior cruciate ligament reconstruction.

Figure 4:

Mean number of morphine milligram equivalents prescribed to patients at the first follow-up visit after anterior cruciate ligament reconstruction.

The group receiving liposomal bupivacaine showed a significantly decreased need for a pain medication refill at the first postoperative follow-up visit (P<.0001). Of the 50 patients in the control group, 28 required a pain medication refill, whereas 1 of the 17 patients in the case group required a pain medication refill. The absolute risk reduction between the control and case groups was 50%, with a number needed to treat of 2.0.

During the first follow-up visit, mean NPRS scores were consistent between groups, 2.8±2.1 in the case group and 3.8±2.4 in the control group (P=.09). Pain scores are shown in Table 4, along with a summary of the data collected. Post hoc power analysis calculated the power of the NPRS score as 47.5%.

Summary of Results

Table 4:

Summary of Results

Discussion

Patients who underwent ACL reconstruction with a pain management protocol using liposomal bupivacaine showed a drastic reduction in postoperative opioid prescriptions. In the case group, postoperative pain was managed successfully with NSAIDs and little, if any, use of opioids. In this group, both the number of opioid pills prescribed and the need for pain medication refill at the first follow-up appointment were lower compared with the control group. These data were consistent with a previous randomized control trial that examined the efficacy of liposomal bupivacaine to reduce opioid use in total knee arthroplasty, bunionectomy, submuscular augmentation mammoplasty, and hemorrhoidectomy.26

The findings of this study did not support the findings of a randomized control trial by Premkumar et al27 that compared liposomal bupivacaine with standard bupivacaine for patients undergoing ACL reconstruction. Although Premkumar et al27 showed a trend toward reduced postoperative opioid use, the difference was not statistically significant. This study was limited by sample size, with only 16 patients in each group. Additionally, Premkumar et al27 did not use the recommended liposomal bupivacaine dilution or infiltrate methods.30 In a study that compared liposomal bupivacaine with a pre-operative femoral nerve block, Okoroha et al28 found that liposomal bupivacaine was not a suitable replacement for peripheral nerve block. Because patients in both the case and control groups of this study received a preoperative femoral nerve block, it is difficult to compare the current findings with the results of the earlier 2 studies.

The ability to substitute opioids for pain management after ACL reconstruction could reduce the detrimental effects of increased patient morbidity and long-term addiction. Although opioids are associated with numerous adverse effects, such as nausea, vomiting, constipation, confusion, and somnolence, it is the risk of respiratory depression that places patients who take opioids at the greatest potential harm, with 1 in 83 patients who use patient-controlled analgesia after surgery requiring naloxone rescue.14 An opioid-sparing protocol is especially important for preventing long-term use because the probability of addiction increases most in the first days of therapy, with a sharp increase after 8 days of use.15 Because orthopedic surgery has a high rate of opioid prescribing,11 it is important to explore strategies to reduce opioid use. This study focused on the use of liposomal bupivacaine intraoperatively to reduce patient need for opioids for pain management after ACL reconstruction. The data showed a notable reduction of 86% in total opioids prescribed and 88% in opioids prescribed at follow-up.

The efficacy of liposomal bupivacaine use in ACL reconstruction also should be measured by its ability to achieve patient-specific goals, such as minimizing recovery time to allow a return to normal activity. Because pain is an important factor in reducing recovery time,2–4 it is important to recognize that the data imply that this opioid-sparing approach minimizes the risk associated with opioid use while maintaining postoperative pain relief. This study assessed pain at the first follow-up visit for both groups. Mean self-reported pain score was lower in the case group compared with the control group, 2.8±2.1 and 3.8±2.4, respectively, although the difference only trended toward statistical significance. This lack of statistical significance between pain scores of the 2 groups may be related to underpowering of the study because post hoc power analysis calculated a power of 47.5%. These findings show that the opioid-sparing technique provided pain relief comparable to that of current standards of care. Further, a reduction in opioid-related side effects may contribute to overall patient comfort and satisfaction.

No recorded deficits in quadriceps function as a result of femoral nerve block occurred beyond the initial perioperative period, although some evidence suggests that quadriceps deficits may occur as a complication of femoral nerve block.31

A major limitation of the current study was sample size. The study included 63 patients, with only 17 receiving liposomal bupivacaine. The authors were limited by the number of cases because the senior surgeon had only recently adopted this technique.

Another confounding variable was the initial number of opioids prescribed to patients. The case group was prescribed a minimal dose of opioids initially, which may have biased patients' expectations and reported pain scores. The change in initial prescribing patterns was primarily a result of the senior surgeon's decision to adopt an opioid-sparing technique, which included the use of liposomal bupivacaine in surgery.26 Opioids were prescribed at the first follow-up appointment based on patient needs.

Additionally, the heterogeneity of graft types between the 2 cohorts potentially may have confounded the results. The case group primarily included quad-ricep autografts, which the control group largely lacked. Interestingly, the control group had significantly more allograft ACL reconstructions. In theory, this could have strengthened the findings because autografts have been linked to increased pain immediately after autograft harvest because of donor site morbidity.32–34 A noticeable difference was seen in the number of semitendinosus autografts in the control group compared with the case group, 21 and 0, respectively. Although femoral nerve block does not cover semitendinosus autograft harvest, no statistical difference was found in pain or the quantity of opioids prescribed for patients who underwent semitendinosus autograft compared with the rest of the control group. Although sciatic nerve block may provide better pain control for patients receiving a semitendinosus autograft, no sciatic nerve blocks were performed in this study. Additional research is needed to determine the efficacy of liposomal bupivacaine compared with sciatic nerve block for ALC reconstruction with semitendinosus autograft.

Additionally, the retrospective nature of this study carries inherent bias. Patient recall bias was minimized because data were collected directly from electronic medical records. Future research should include prospective randomized controlled trials with much larger samples.

Conclusion

There has been a call for health care providers to limit the quantity of opioids prescribed because of the substantial increase in prescription opioid overdoses in the United States. This study describes an opioid-sparing multimodal pain management protocol that may be used in ACL reconstruction surgery. The data are compelling because they suggest that a pain management protocol that uses liposomal bupivacaine may dramatically minimize the risks associated with opioid prescriptions while maintaining the pain relief seen with more traditional pain management therapy.

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Exclusion Criteria

CriterionNo.a
Insufficient electronic medical record documentation24
Prescribed opioids ≤90 days before surgery9
Polytrauma that required additional pain management5
Multiligamentous reconstruction5
Age <18 y3
Follow-up >30 days after surgery3
Revision anterior cruciate ligament reconstruction1
Deep venous thrombosis1
Total51

Graft Type Used for Anterior Cruciate Ligament Reconstruction

Graft typeNo.

Control group (n=50)Case group (n=17)
Semitendinosus autograft210
Semitendinosus allograft133
Quadricep auto-graft112
No graft (anterior cruciate ligament repair)152

Type of Surgery Performed

ProcedureNo.

Control group (n=50)Case group (n=17)
Anterior cruciate ligament repair only142
Anterior cruciate ligament reconstruction only133
Anterior cruciate ligament reconstruction+meniscus repair55
Anterior cruciate ligament reconstruction+partial meniscectomy125
Anterior cruciate ligament reconstruction+chondroplasty21
Anterior cruciate ligament reconstruction+partial meniscectomy+chondroplasty01
Anterior cruciate ligament reconstruction+partial meniscal repair+chondroplasty40

Summary of Results

Factor of interestCase group (n=17)Control group (n=50)P
5-mg oxycodone tablets prescribed, mean±SD, No.9.29±10.29a66.26± 7.13a<.0001
5-mg oxycodone tablets prescribed at first follow-up visit, mean±SD, No.2.35±9.70a20.20±21.99a<.0001
Milligram morphine equivalents prescribed, mean±SD69.71±77.21a532.24±275.19a<.0001
Milligram morphine equivalents prescribed at first follow-up visit, mean±SD17.64±72.76a164.50±165.99a<.0001
Patients who needed pain medication refill at first follow-up visit, No.1a28a<.0001
Self-reported pain scoreb during first follow-up visit, mean±SD2.8±2.13.8±2.4.09
Authors

The authors are from Georgetown University School of Medicine (BTS, PMS, MK, BMB), George Washington University (HTS), and Med-Star Washington Hospital Center (SL, EHA), Washington, DC.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Brandon T. Stryder, MS, Georgetown University School of Medicine, 3900 Reservoir Rd NW, Washington, DC 20007 ( bst31@georgetown.edu).

Received: October 17, 2019
Accepted: March 19, 2020
Posted Online: January 07, 2021

10.3928/01477447-20210104-03

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