Total knee arthroplasty (TKA) is a successful procedure for the treatment of knee arthritis.1 Postoperative pain can have negative effects on patients' ability to mobilize after surgery. Narcotic use after surgery can also prolong hospital stays because of side effects. Multimodal pain management pathways have been successful in decreasing postoperative pain and limiting narcotic use.2 Periarticular injections (PAIs) have the benefit of analgesia without neuromuscular blockade, allowing for early and rapid patient mobilization.
Liposomal bupivacaine was developed for injection at the surgical site with the potential for extended analgesia. The novel delivery system contains bupivacaine within a carrier molecule that allows gradual release over an extended period. Multiple studies have reported successful results and improvement in postoperative analgesia with liposomal bupivacaine.3,4 However, studies directly comparing liposomal bupivacaine with plain bupivacaine have reported inconsistent results, some of which indicate inferior pain control with liposomal bupivacaine.5–7 A criticism and potential explanation for inferior pain control with liposomal bupivacaine has been the delayed release of the bupivacaine from the liposomes.8,9 This has led to surgeons' adding free bupivacaine to provide immediate analgesia until the liposomal bupivacaine is released.
Ropivacaine is another local anesthetic with an extended duration of analgesia. Other medications have been added to local anesthetics in PAIs to block the pain pathway at other locations. These adjuvants include ketorolac, corticosteroids, morphine, and clonidine.10 Few studies have compared liposomal bupivacaine with ropivacaine as a component of a PAI cocktail with these adjuvants.
The purpose of this study was to compare liposomal bupivacaine with ropivacaine when used in PAI cocktails for TKA. Outcome variables included pain scores, length of stay (LOS), range of motion (ROM), and clinical outcomes. A cost comparison was performed to determine if liposomal bupivacaine is a cost-effective medication for use in multimodal pain management after TKA.
Materials and Methods
After receiving institutional review board approval, the records of patients who received a primary TKA between September 2013 and January 2016 were retrospectively reviewed. Data were collected on patients who underwent TKA performed by two fellowship-trained arthroplasty surgeons (M.J.D., B.M.F.). All surgeries were performed with cemented implants, both cruciate retaining and posterior stabilized. The two surgeons used similar surgical techniques consisting of a combination of measured resection with anatomic landmarks and ligamentous balancing. All patients received preoperative celecoxib, oxycodone, and intravenous acetaminophen as part of a multimodal pain control protocol. Each patient received an intraoperative local injection with a multi-modal medication regimen, varying only with ropivacaine (300 mg of ropivacaine, 30 mg of ketorolac, 8 mg of clonidine, and 1 mg of epinephrine) or liposomal bupivacaine/free bupivacaine combination (266 mg of liposomal bupivacaine, 93 mg of bupivacaine, 30 mg of ketorolac, 8 mg of clonidine, and 1 mg of epinephrine). The control group had ropivacaine only, while the study group had liposomal bupivacaine and free bupivacaine. Twenty-four patients with incomplete ROM data were excluded.
Demographic data were also collected, including sex, age at the time of surgery, and operative side. Preoperative narcotic use was also recorded and converted to standard morphine equivalents for comparison.11 Narcotic use was defined as greater than 6 weeks of narcotic consumption prior to surgery with no association to a separate surgical procedure. A prescription for narcotic pain medication after the first of two staged bilateral procedures 6 weeks apart did not count as preoperative narcotic use for the second procedure. Type of anesthesia was recorded due to its potential effects on pain scores, postoperative ROM, and ambulation measures. All patients received either general endotracheal anesthesia alone, spinal anesthesia alone, or general endotracheal anesthesia with a regional nerve block (femoral, sciatic, or adductor canal). The total LOS in the hospital was recorded from the documented “time in the operating room” on the anesthesia log to the time of discharge, which was recorded as the time of the nurse's discharge note. Postoperatively, visual analog scale (VAS) pain scores, ROM, and ambulation distance were collected at set time points. Visual analog scale pain scores were collected every 8 hours for the length of hospital stay up to 2 days postoperatively. Ambulation and ROM measures were recorded on postoperative days 0, 1, and 2 as documented by a physical therapist. Range of motion measures at 2 weeks and 6 weeks following surgery were documented by the attending physician. Further, Knee Society Scores (KSS) from both before and after surgery were collected.
Following data collection, statistical analysis consisted of chi-square tests for categorical data and Student's t tests for continuous data. Statistical significance was set at P<.05.
The total number of patients included in the study was 242. Of 242 patients who underwent primary TKA, 88 (36.36%) patients were in the control group receiving the ropivacaine cocktail and 154 (63.64%) were in the study group receiving the liposomal bupivacaine cocktail. The 88 surgeries in control patients were distributed equally between the two surgeons, each with 44. In the study group, the 154 surgeries were distributed differently between the two surgeons—97 and 57.
There were no major differences in preoperative demographic values. Demographic comparisons and P values are summarized in Table 1.
Outcomes of interest were LOS, VAS pain scores, distance walked, ROM, and KSS. There was a statistically significant difference with LOS when comparing the control group with the study group (51 hours vs 73 hours; P=.04). Pain scores were recorded as a mean per 8-hour shift starting at the time of surgery. They were lower for the control group at every time point, but only statistically significant at the 23 to 32 hours postoperative time point (4.7 vs 5.5; P=.004). There was no difference in ROM except at the 2-week postoperative visit. The control group had a mean arch of motion of 98° compared with a mean arch of motion of 94° in the study group (P=.04). Distance walked was also recorded and showed no statistical significance on the day of surgery, postoperative day 1, or postoperative day 2. The KSS was documented for patients at their 6-week follow-up visit. There was no significant difference between the two groups, with the control group having a mean score of 63 and the study group having a mean score of 84 (P=.46). There was one manipulation under anesthesia for postoperative arthrofibrosis in the control group and none in the study group (P=.71).
The authors also calculated the total morphine equivalents administered to patients during their hospitalization. The mean morphine equivalent was 987 for the control group and 640 for the study group (P=.27), which was not statistically significant. Although the difference in morphine equivalents appeared large between the two groups, the jackknife analysis identified two significant outliers within the control group—one in the 7th and one in the 12th standard deviation of the mean. These have influential bias that skews this measurement. The cost was $329.60 for the liposomal bupivacaine cocktail vs $19.36 for the ropivacaine cocktail as calculated in the authors' hospital system.
Periarticular injections have been shown to be an effective method for postoperative analgesia in TKA.12,13 The ideal type, composition, and delivery method for these injections have been debated without a clearly superior method described.14–16 Liposomal bupivacaine has become a popular form of PAI with the hopes of providing superior analgesia with a longer duration of action.4 However, this medication has had mixed results in the literature.12–15 A criticism of liposomal bupivacaine's delivery mechanism is the delayed onset of analgesia; this delay could contribute to the findings of increased early postoperative pain with this medication.8,9 Another criticism of studies of liposomal bupivacaine is the lack of added components of popular PAI cocktails. These components include epinephrine, ketorolac, clonidine, steroid, morphine, and so on. The preferred technique for liposomal bupivacaine injection has been well documented14–16; failure to follow the suggested technique could have an impact on the efficacy of the injection.
The current study meant to address the above concerns with liposomal bupivacaine while having an equal comparison with another long-acting local anesthetic. To accomplish this goal, the study design compared liposomal bupivacaine with ropivacaine as part of a multimodal injection cocktail. Both groups contained the same epinephrine, ketorolac, and clonidine. To address the delayed release from liposomes, regular bupivacaine was added to the liposomal injection to provide early analgesia. In the two groups, injections were administered using the same recommended technique, which included the reticulum, vastus medialis, posterior capsule, and periosteum.
Both injections showed favorable postoperative pain scores, LOS, distance walked, and ROM. The ropivacaine group showed statistically better pain scores at 23 to 32 hours after surgery and mean scores during the entire hospitalization. This group also showed a statistically shorter LOS and greater knee ROM at 2 weeks. There were no other differences in pain scores or ROM at any other time point or in rates of manipulation under anesthesia, KSS, narcotic requirements, or distance walked between the two groups.
The statistically significant differences were seen in a few parameters, with all favoring ropivacaine over liposomal bupivacaine. These parameters included lower VAS pain score at postoperative hours 23 to 32, lower mean VAS pain score during the entire hospitalization, shorter LOS, and increased knee ROM. There were no differences in pain scores, narcotic requirements, ROM, or distance walked at any other time points between the groups. There were no differences in KSS or the incidence of manipulation under anesthesia between the groups. It appears that there is no increased benefit of using liposomal bupivacaine over ropivacaine in perioperative pain cocktails. It has been reported that the average cost for 266 mg (20 cc) of liposomal bupivacaine mixed with 75 mg (30 cc) of bupivacaine is $285, and that the approximate cost of 150 mg (60 cc) of bupivacaine is $2.80.16,17 Corroborated by the current authors' hospital system's cost, this difference in cost, without proof of statistical or clinical significance, makes the use of ropivacaine even more suitable.
Kuang et al12 published a meta-analysis concluding that there is no greater efficacy with liposomal bupivacaine compared with conventional periarticular bupivacaine when assessing for VAS pain score, opioid consumption, ROM, LOS, and postoperative nausea. Singh et al13 recently performed a meta-analysis examining the role of liposomal bupivacaine periarticular infiltration for pain control in patients undergoing TKA. Their results showed few statistically significant advantages of liposomal bupivacaine over conventional bupivacaine. They did report improved pain control with respect to shortened hospital stay and lower pain scores through postoperative day 1 with liposomal bupivacaine; however, the analysis examined all studies involving liposomal bupivacaine PAI, including its comparison with regional nerve blocks, epidural blocks, multimodal injections, and a parenteral opioid pain regimen.13
As can be expected, pain control and postoperative function are improved with a PAI of liposomal bupivacaine compared with the alternative of no PAI or a placebo injection with saline.4,18 The safety of injecting liposomal bupivacaine alone or in combination with bupivacaine hydrochloride has been proven in multiple studies, showing safe serum levels and no adverse cardiac or neurologic events. It was even noted by Buys et al19 that performing bilateral TKAs with bilateral PAIs remained safe, with systemic levels well below toxicity levels. This observation does not negate the fact that patients can only receive a certain amount of amide-substrate medications based on their weight and liver function.
Multiple studies have shown that PAIs using liposomal bupivacaine are superior to epidural anesthesia; one study showed that the PAI group had statistically significant decreases in pain score, shorter length of hospital stay, and a longer distance walked on postoperative day 1 compared with the epidural anesthesia group.20 Barrington et al21 also supported the use of PAI using liposomal bupivacaine over spinal anesthesia alone.
Research has shown that liposomal bupivacaine PAIs are superior to femoral nerve blocks both economically and clinically. In addition to shorter LOS and decreased VAS pain scores, there are studies showing a decrease in the number of inpatient physical therapy sessions, that patients are more likely to complete physical therapy milestones such as ambulating 100 feet and walking up stairs, that patients are less likely to fall during their hospital stay, and that the hospital cost is approximately $2000 less in the PAI group compared with the regional block group.22–25 These data were corroborated by Kirkness et al,26 who also reported earlier ambulation, greater ambulation distance, larger percentage of patients discharged within 2 days postoperatively, shorter LOS, and, although not statistically significant, decreased hospital costs with liposomal bupivacaine compared with continuous femoral nerve block using bupivacaine. However, the postsurgical pain scores and opioid use were similar in the two groups.26 Most of the functional improvement favoring PAI over regional nerve blocks results from its elimination of motor weakness seen with isolated regional nerve blocks. Periarticular injections were also supported over regional nerve blocks by Sporer and Rogers27 in their study comparing a single-dose bupivacaine femoral nerve block in combination with bupivacaine PAI with a 60-cc PAI alone (combination of 20 cc of liposomal bupivacaine and 30 cc of bupivacaine). The isolated PAI without the regional block required less breakthrough pain medication and resulted in lower pain scores 12 hours postoperatively and shorter time to ambulation.27
The only conclusive data that these studies support are multimodal pain control with PAIs over other isolated non-local modes of anesthesia. Previous studies have focused on the comparison of liposomal bupivacaine with conventional periarticular infiltration, regional nerve blocks, or intravenous multimodal regimens. There are few studies directly comparing liposomal bupivacaine with a non-liposomal form of bupivacaine without confounding variables. Even more specifically, the current study made the liposomal carrier of bupivacaine the only variable of the authors' pain control technique, allowing for direct correlation of their results to the efficacy of liposomal bupivacaine itself. Other studies that have attempted to do the same by comparing a multimodal cocktail with and without liposomal bupivacaine have reported similar results of either non-inferiority to free bupivacaine or improved outcomes with free bupivacaine.21,28–30 Some studies have compared a multidrug cocktail otherwise known as the modified Ranawat suspension, which includes a mixture of ropivacaine, epinephrine, ketorolac, and clonidine, with an injection of only liposomal bupivacaine. Some of these studies have shown no benefit to liposomal bupivacaine over the multidrug cocktail using bupivacaine,5,7,17 whereas others have found statistical evidence that liposomal bupivacaine decreases pain scores, narcotic use, and adverse events while increasing patient satisfaction.31–33 Even among chronic opioid users, Schwarzkopf et al7 found no benefit in relation to narcotic consumption or pain scores to using liposomal bupivacaine. Collis et al34 found no difference in pain levels, narcotic consumption, and ROM; however, that study did find improved walking distance in the liposomal bupivacaine group. Bagsby et al8 found that liposomal bupivacaine provided inferior pain control compared with a traditional periarticular multimodal injection.
Schumer et al35 randomized patients to receive wound infiltration with either liposomal bupivacaine or standard bupivacaine along with spinal anesthesia. They found no significant difference between pain scores or hospital LOS. Britten et al36 performed a study similar to the current study comparing a multimodal injection with ropivacaine with a liposomal bupivacaine injection. They found no difference in total opioid use, pain scores, or LOS between groups.36 Hyland et al37 performed a prospective, randomized trial comparing PAIs using liposomal bupivacaine with standard bupivacaine. They found no differences in number of therapy sessions necessary for discharge, total opioid consumption, or pain scores.
There is concern that injection technique can produce different results based on needle gauge and length, amount of suspension injected, and number of sites injected.14–16 However, according to the study by Meneghini et al,6 there was no difference in the outcomes when comparing an optimized injection technique of liposomal bupivacaine, a traditional injection technique of liposomal bupivacaine, and a conventional multimodal PAI containing ropivacaine.6 In addition, the American Association of Hip and Knee Surgeons clinical research award was granted to Jain et al38 for their finding that there was no difference in PAIs of either liposomal bupivacaine or ropivacaine when compared with a single intra-articular injection of bupivacaine and morphine.
There were several limitations to this study. It was a retrospective study using medical records to extract data on patients who had already undergone surgery. The goal of the study was to determine if a change in the authors' practice by switching to liposomal bupivacaine was cost-effective. A randomized controlled trial would eliminate any potential bias inherent to retrospective studies. Two different surgeons participated in the study, which could have introduced confounding variables such as small differences in surgical technique. Three different modes of anesthesia were used, which could have added confounding variables. However, the majority of the cases were performed under spinal anesthesia and the distribution of anesthesia was similar between groups. There was an unexplained discrepancy in the control group between the nonsignificant trend toward higher morphine equivalents and the decreased VAS pain scores. There was also an unexplained discrepancy in the control group between the nonsignificant lower KSS at 6 weeks and the other equivalent or superior results noted.
This study compared liposomal bupivacaine with ropivacaine when used in a multimodal PAI for TKA. Bupivacaine added to liposomal bupivacaine addressed the delayed onset of the medication and gave an accurately matched comparison with the ropivacaine injection. All outcomes tested with liposomal bupivacaine were either equivalent or inferior to those tested with ropivacaine. When used as a component of a PAI, liposomal bupivacaine offers no advantages over ropivacaine and has a considerably higher cost.
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- Klug MJ, Rivey MP, Carter JT. Comparison of intraoperative periarticular injections versus liposomal bupivacaine as part of a multimodal approach to pain management in total knee arthroplasty. Hosp Pharm. 2016;51(4):305–311. https://doi.org/10.1310/hpj5104-305 PMID: doi:10.1310/hpj5104-305 [CrossRef]27303078
- Meneghini RM, Bagsby D, Ireland PH, Ziemba-Davis M, Lovro LR. Liposomal bupivacaine injection technique in total knee arthroplasty. J Knee Surg. 2017;30(1):88–96. PMID:27119965
- Schwarzkopf R, Drexler M, Ma MW, et al. Is there a benefit for liposomal bupivacaine compared to a traditional periarticular injection in total knee arthroplasty patients with a history of chronic opioid use?J Arthroplasty. 2016;31(8):1702–1705. https://doi.org/10.1016/j.arth.2016.01.037 PMID: doi:10.1016/j.arth.2016.01.037 [CrossRef]26897490
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|Variable||PAI–LB (n=154, 63.64%)||PAI–R (n=88, 36.36%)||P|
|Age, mean, y||61.81||61.69||.92|
|Preoperative narcotic use||27.92%||23.86%||.49|
| General + RB||4.55%||7.95%|