BACKGROUND: Local anesthetic administered directly to the operative site by slow infusion has become a popular supplementary pain management strategy following rotator cuff surgery, but it is expensive and there is little conclusive evidence that it provides additional benefits. The purpose of this study was to determine the effectiveness and safety of ropivacaine infusion following arthroscopic or mini-incision rotator cuff surgery. METHODS: We performed a randomized, participant and outcome assessor-blinded, placebo-controlled trial. Participants, stratified by operative procedure (either arthroscopic decompression or rotator cuff repair), were given preemptive 1% ropivacaine (20 mL) and intraoperative intravenous parecoxib (40 mg) and were randomly assigned to 0.75% ropivacaine or placebo by elastomeric pump at 5 mL/hr. Pain at rest was reported on a verbal analogue scale at fifteen, thirty, and sixty minutes and at two, four, eight, twelve, eighteen, and twenty-four hours. The use of alternative analgesia, delay in discharge, and adverse events, including development of stiff painful shoulder, infection, and leakage, were also assessed. RESULTS: Eighty-eight participants received arthroscopic decompression (forty-three in the placebo arm and forty-five in the ropivacaine arm) and seventy received rotator cuff repair (thirty-five participants in each treatment arm). Compared with placebo, ropivacaine infusion resulted in a significant but clinically unimportant improvement in average pain in the first twelve hours following both procedures (the average pain score was 1.62 and 2.16 for the ropivacaine and placebo arms, respectively, in the arthroscopic decompression group and 2.12 and 2.82 in the rotator cuff repair group, with a pooled difference between groups of 0.61; 95% confidence interval, 0.22 to 1.01; p = 0.003). When adjusted for opioid use, the pooled difference between groups was 0.49 (95% confidence interval, 0.12 to 0.86; p = 0.009). No difference was detected between groups with regard to the maximum pain in the first twelve hours or the average or maximum pain in the second twelve hours, with or without adjustment for opioid use, and no difference was found between groups with regard to the amount of oral analgesia used. No difference was detected between groups with regard to the prevalence of nausea and vomiting, catheter leakage, delayed discharge, or stiff painful shoulder, and no participant in either group had a postoperative infection develop. CONCLUSIONS: We found minimal evidence to support the use of ropivacaine infusion for improving outcomes following rotator cuff surgery in the setting of preemptive ropivacaine and intraoperative parecoxib.
RCT Entities:
BACKGROUND: Local anesthetic administered directly to the operative site by slow infusion has become a popular supplementary pain management strategy following rotator cuff surgery, but it is expensive and there is little conclusive evidence that it provides additional benefits. The purpose of this study was to determine the effectiveness and safety of ropivacaine infusion following arthroscopic or mini-incision rotator cuff surgery. METHODS: We performed a randomized, participant and outcome assessor-blinded, placebo-controlled trial. Participants, stratified by operative procedure (either arthroscopic decompression or rotator cuff repair), were given preemptive 1% ropivacaine (20 mL) and intraoperative intravenous parecoxib (40 mg) and were randomly assigned to 0.75% ropivacaine or placebo by elastomeric pump at 5 mL/hr. Pain at rest was reported on a verbal analogue scale at fifteen, thirty, and sixty minutes and at two, four, eight, twelve, eighteen, and twenty-four hours. The use of alternative analgesia, delay in discharge, and adverse events, including development of stiff painful shoulder, infection, and leakage, were also assessed. RESULTS: Eighty-eight participants received arthroscopic decompression (forty-three in the placebo arm and forty-five in the ropivacaine arm) and seventy received rotator cuff repair (thirty-five participants in each treatment arm). Compared with placebo, ropivacaine infusion resulted in a significant but clinically unimportant improvement in average pain in the first twelve hours following both procedures (the average pain score was 1.62 and 2.16 for the ropivacaine and placebo arms, respectively, in the arthroscopic decompression group and 2.12 and 2.82 in the rotator cuff repair group, with a pooled difference between groups of 0.61; 95% confidence interval, 0.22 to 1.01; p = 0.003). When adjusted for opioid use, the pooled difference between groups was 0.49 (95% confidence interval, 0.12 to 0.86; p = 0.009). No difference was detected between groups with regard to the maximum pain in the first twelve hours or the average or maximum pain in the second twelve hours, with or without adjustment for opioid use, and no difference was found between groups with regard to the amount of oral analgesia used. No difference was detected between groups with regard to the prevalence of nausea and vomiting, catheter leakage, delayed discharge, or stiff painful shoulder, and no participant in either group had a postoperative infection develop. CONCLUSIONS: We found minimal evidence to support the use of ropivacaine infusion for improving outcomes following rotator cuff surgery in the setting of preemptive ropivacaine and intraoperative parecoxib.
Authors: Sang Hun Ko; Sung Do Cho; Chae Chil Lee; Jang Kyu Choi; Han Wook Kim; Seon Jae Park; Mun Hee Bae; Jae Ryong Cha Journal: Clin Orthop Surg Date: 2017-08-04