BACKGROUND: Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. OBJECTIVE: To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. DESIGN: A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. SETTINGS: Community hospital with general surgery residency program with all cases performed by colorectal surgeons. PATIENTS: Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. INTERVENTIONS: Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. MAIN OUTCOME MEASURES: Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. RESULTS: There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). LIMITATIONS: Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. CONCLUSIONS:Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).
RCT Entities:
BACKGROUND: Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. OBJECTIVE: To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. DESIGN: A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. SETTINGS: Community hospital with general surgery residency program with all cases performed by colorectal surgeons. PATIENTS: Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. INTERVENTIONS: Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. MAIN OUTCOME MEASURES: Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. RESULTS: There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). LIMITATIONS: Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. CONCLUSIONS: Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).
Authors: Adam C Fields; Scott G Weiner; Luisa J Maldonado; Paul M Cavallaro; Nelya Melnitchouk; Joel Goldberg; Matthias F Stopfkuchen-Evans; Olesya Baker; Liliana G Bordeianou; Ronald Bleday Journal: Int J Colorectal Dis Date: 2019-12-04 Impact factor: 2.571