The regression model for the VAS pain score at 24 hours postoperatively was significant (p < 0.001, r2 = 0.19); however, the model for total postoperative narcotic requirement (morphine equivalent units over 24 hours) (p = 0.49, r2 = 0.05) was not significant. On linear regression analysis, higher VAS pain score at 24 hours postoperatively was significantly associated with younger age (p = 0.005, −0.1 VAS point per year of age), history of depression (p = 0.038), higher Charlson Comorbidity Index score (p = 0.035, +0.4 VAS point per point of Charlson Comorbidity Index score), and higher preoperative VAS pain score (p = 0.003, +0.2 VAS point per point of preoperative VAS score).
Patients treated with periarticular local anesthetic infiltration of bupivacaine liposome injectable suspension required equivalent postoperative narcotics and greater intraoperative narcotics compared with patients treated with interscalene brachial plexus blockade. Although interscalene brachial plexus blockade provided improved pain scores for the first 8 hours postoperatively, pain scores were higher at 24 hours compared with local anesthetic infiltration of bupivacaine liposome injectable suspension. We attribute these findings to the experience of rebound pain in patients undergoing interscalene brachial plexus blockade.
The benefits of interscalene brachial plexus blockade in shoulder surgical procedures have been reported25,26. Abdallah et al. performed a meta-analysis to examine the effect of interscalene brachial plexus blockade on analgesic outcomes during the first 48 hours after a shoulder surgical procedure25. A total of 23 randomized controlled trials, including 1,090 patients, were analyzed. Similar to our findings, the authors demonstrated that interscalene brachial plexus blockade can provide effective analgesia up 8 hours after a shoulder surgical procedure, with no demonstrable benefits thereafter. Additionally, they showed that patients who received an interscalene brachial plexus blockade experienced rebound pain at 24 hours. We demonstrated a change in pain score from 1.4 to 4.9 points between 8 and 24 hours after a surgical procedure in the interscalene brachial plexus blockade group, which was consistent with the experience of rebound pain. It was this increased pain during the first 24 hours after a surgical procedure that we believe accounted for the increased postoperative narcotic usage in patients who underwent an interscalene brachial plexus blockade.
Bupivacaine liposome injectable suspension has been shown in previous studies to be safe for local soft-tissue infiltration at the time of the surgical procedure18,19. Interestingly, the analgesic effect of this suspension remained consistent for the first 24 hours after shoulder arthroplasty. Despite this, approximately 19% of patients in the local soft-tissue infiltration group had pain scores of >5 in the PACU; it does not appear that bupivacaine liposome injectable suspension alone is sufficient for optimal postoperative pain control after shoulder arthroplasty in all patients. Interestingly, despite improved pain relief at 0 hours postoperatively in the interscalene brachial plexus blockade group, almost 8% of patients had VAS pain scores of >5 in the PACU. Possible reasons for this include failure of the interscalene brachial plexus blockade or pain in the axillary region of the shoulder that is typically not addressed by an interscalene brachial plexus blockade.
It is important to note that alternative methods of soft-tissue infiltration, such as non-liposome injectable bupivacaine or previously described infiltration cocktails15, were not compared in this study. As a result, it is unknown whether the lack of rebound pain experience seen in patients in the soft-tissue infiltration group was due to the injection of bupivacaine liposome injectable suspension or simply a consequence of patients in this group not undergoing an interscalene brachial plexus blockade. Abdallah et al. reported that, after a shoulder surgical procedure, the mean pain scores were 4.96 at 8 hours postoperatively and 4.62 at 16 hours postoperatively in control subjects who did not undergo interscalene brachial plexus blockade25. This is compared with 3.2 at 8 hours postoperatively and 3.8 at 16 hours postoperatively in our subjects who underwent periarticular local anesthetic infiltration of bupivacaine liposome injectable suspension. On the basis of these historic data, there may be an analgesic benefit provided by the bupivacaine liposome injectable suspension.
Based on the regression analysis, it appears that certain demographic factors are associated with higher pain scores at 24 hours after a surgical procedure, regardless of the analgesic technique used. Younger patients were noted to have higher pain scores at 24 hours after a surgical procedure. Gold et al. showed that younger patients were more likely to require long-acting opioids after undergoing a joint replacement surgical procedure27. Depression and greater Charlson Comorbidity Index scores were also associated with greater pain scores at 24 hours after the surgical procedure. Menendez et al. showed that psychological distress is associated with greater perceived disability and pain in patients with shoulder disease28. Tashjian et al. showed that medical comorbidities can have a negative impact on self-reported pain experience in patients with chronic rotator cuff tears29, but that the ultimate outcome of a surgical procedure is not necessarily impacted by greater comorbid conditions30. Finally, a higher preoperative VAS pain score was associated with a higher VAS pain score at 24 hours after a surgical procedure. Similarly, Williams et al. reported that higher preoperative pain scores were correlated with higher acute postoperative pain scores after rotator cuff repair31. Because these factors were associated with higher pain scores regardless of the analgesic technique used, it appears that patients at high risk for postoperative pain experience may not be adequately treated with either interscalene brachial plexus blockade or local soft-tissue infiltration with bupivacaine liposome injectable suspension.
This study had a number of weaknesses. As discussed above, this study did not include a negative control group of subjects who did not undergo local soft-tissue infiltration or interscalene brachial plexus blockade. The study was designed in this manner because of ethical concerns related to denying patients pain management strategies known to be effective. Additionally, we utilized single-injection interscalene brachial plexus blockade in this study, as it is the standard of care at our hospital. It is likely that interscalene brachial plexus blockade with placement of a catheter for continuous infusion of analgesic medication would have resulted in longer-lasting pain relief. Another weakness is that patient pain scores and narcotic utilization were only evaluated over the first 24 hours after a surgical procedure. Although it is possible that differences between the interscalene brachial plexus blockade and local soft-tissue infiltration would be significant beyond the first 24 hours after a surgical procedure, previous studies have indicated no difference between pain intensity between 24 and 72 hours after a surgical procedure in control subjects and those receiving soft-tissue infiltration with bupivacaine liposome injectable suspension22,23. With regard to the rebound pain after 24 hours, multiple studies of soft-tissue infiltration with liposomal bupivacaine in orthopaedic and non-orthopaedic surgery have not demonstrated the presence of rebound pain experience beyond 24 hours32-35. Also, because many patients were discharged on the first postoperative day, additional data acquisition would have required greater resources for data collection. Given a goal to perform this investigation without industry support, we chose to fund this study internally and to evaluate patients only during the first 24 hours. Although reported narcotic usage in terms of morphine equivalent units is common in the literature14,32-34, there is growing concern that a single, effective method does not exist that allows opioids to be accurately and consistently converted to another opioid36. A cost analysis would be an important adjunct to this investigation; however, the necessary charge and reimbursement data were not available and this study was not designed in a manner to perform an accurate cost-effectiveness analysis. Finally, although the injection technique was standardized among the investigators, there were no predicate data from the literature to guide an optimal injection technique; additionally, a formal evaluation of the success of our standardization process was not performed. As a result, it is possible that variability in injection techniques could lead to greater difference in outcomes in the soft-tissue infiltration group. Despite this, we believe that this variability more closely replicates the true clinical situation and would not be expected to be substantially different from the variability present in the performance of interscalene brachial plexus blockade.
On the basis of our findings, bupivacaine liposome injectable suspension appears to be a viable alternative to interscalene brachial plexus blockade. Although interscalene brachial plexus blockade provides optimal pain relief for the first 8 hours after a surgical procedure, there is an associated cost of rebound pain after 8 hours. Bupivacaine liposome injectable suspension does not result in rebound pain during the first 24 hours after a surgical procedure, but pain relief for the first 8 hours after a surgical procedure is less predictable. As a result, the optimal pain regimen for shoulder arthroplasty and the cost-effectiveness of analgesic techniques require further investigation.
NOTE: The authors acknowledge the efforts of Daniel Sholder in patient recruitment and enrollment in this investigation and Mitchell Maltenfort for statistical support.
Investigation performed at the Department of Orthopaedic Surgery, Rothman Institute, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania
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