Local infiltration with cocktail analgesics during 2 level lumbar spinal fusion surgery: Study protocol of a randomized controlled trial

BACKGROUND: Despite introducing novel analgesics, pain management for spine surgery remains a challenge. Multimodal pain control has recently gained popularity in surgical spine care. We proposed a novel management approach using multimodal cocktail analgesics. Injection to skin surrounding surgical incision site will be given perioperatively. This study evaluates the safety and efficacy of cocktail analgesic injection on pain management following lumbar spinal fusion surgery. METHODS: Thirty-six patients with degenerative lumbar spinal diseases on the waiting list for lumbar spinal fusion surgery will be recruited. Patients will be randomly assigned to receive either cocktail analgesic injection or sterile saline before surgical wound closure. All patients will routinely receive postoperative intravenous patient-controlled analgesia (IV-PCA) with sufentanil on an as-needed basis without a basal dose. The primary outcome is perceived pain intensity as measured by visual analog pain score. Secondary outcomes include sufentanil consumption, time to first use of IV-PCA, rescue analgesics consumption, and the presence of adverse effects. Findings of this interventional trial will provide novel evidence supporting the superior effect of cocktail analgesic injection during surgery. TRIAL REGISTRATION NUMBER: ChiCTR-IPR-17013094.