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Efficacy of Subacromial Ropivacaine Infusion for Rotator Cuff Surgery

A Randomized Trial

¹ Monash Department of Clinical Epidemiology at Cabrini Hospital and Department of Epidemiology and Preventive Medicine, Monash University, Suite 41, Cabrini Medical Centre, 183 Wattletree Road, Malvern, Victoria 3144, Australia. E-mail address for R. Buchbinder: rachelle.buchbinder{at}med.monash.edu.au
² Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, 89 Commercial Road, Melbourne, Victoria 3004, Australia
³ Upper Limb Unit, Monash Medical Centre Division of Orthopaedics, Monash University Department of Surgery, Melbourne, and The Melbourne Shoulder and Elbow Centre, 31 Normanby Street, Brighton, Victoria 3186, Australia

Investigation performed at the Cabrini Institute and Monash University, Victoria, Australia

Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants of less than $10,000 from the Victorian Orthopaedic Research Trust, Melbourne, Australia, and funding of less than $10,000 from an Australian National Health and Medical Research Practitioner Fellowship. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

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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.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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