STUDY DESIGN: A bicenter randomized, patients, healthcare providers, and data collectors blind placebo-controlled trial in multimodal analgesia for postoperative lumbar spine surgery was conducted. OBJECTIVE: To assess the efficacy and safety of parecoxib on postoperative pain managementafter posterior lumbar spine surgery. SUMMARY OF BACKGROUND DATA: Systematic reviews suggest that cyclo-oxygenase-2 inhibitors are an effective treatment for acute postoperative pain. However, previous trials on lumbar spine surgery showed equivocal efficacy of cyclo-oxygenase-2 inhibitors for postoperative pain relief. METHODS: In this study, 120 patients undergoing posterior lumbar discectomy, spinal decompression, or spinal fusion were stratified based on the surgical procedure to 3 groups (n = 40) and randomly allocated to receive multidoses of parecoxib 40 mg/dose or placebo. Efficacy was assessed by total morphine used from patient-controlled analgesic pump, pain intensity, pain relief, and the patient's subjective rating of the medication. RESULTS:Parecoxib 40 mg reduced the total amount of morphine required over 48 hours by 39% relative morphine reduction compared with placebo (P = 0.0001). Pain at rest was reduced by 30% (P = 0.0001). Ninety percent of patients given parecoxib experienced at least 50% maximum total pain relief compared with 58% treated with placebo. The number-needed-to-treat for 1 patient to have at least half pain relief was 3.1 (2.0-4.6). Patients' subjective rating of the medication was described as "excellent, good, and fair" by 48%, 43%, and 8% in the parecoxib group, respectively, compared with 21%, 50%, and 28% of placebopatients (P = 0.004). Overall adverse effects of patients receiving parecoxib and morphine were comparable to those receiving morphine alone. CONCLUSION: The present study demonstrates that the perioperative administration of parecoxib with patient-controlled analgesic morphine after lumber spine surgery resulted in significantly improved postoperative analgesic management as defined by reduction in opioid requirement, lower pain scores, and higher patients' subjective rating of the medication.
RCT Entities:
STUDY DESIGN: A bicenter randomized, patients, healthcare providers, and data collectors blind placebo-controlled trial in multimodal analgesia for postoperative lumbar spine surgery was conducted. OBJECTIVE: To assess the efficacy and safety of parecoxib on postoperative pain management after posterior lumbar spine surgery. SUMMARY OF BACKGROUND DATA: Systematic reviews suggest that cyclo-oxygenase-2 inhibitors are an effective treatment for acute postoperative pain. However, previous trials on lumbar spine surgery showed equivocal efficacy of cyclo-oxygenase-2 inhibitors for postoperative pain relief. METHODS: In this study, 120 patients undergoing posterior lumbar discectomy, spinal decompression, or spinal fusion were stratified based on the surgical procedure to 3 groups (n = 40) and randomly allocated to receive multidoses of parecoxib 40 mg/dose or placebo. Efficacy was assessed by total morphine used from patient-controlled analgesic pump, pain intensity, pain relief, and the patient's subjective rating of the medication. RESULTS:Parecoxib 40 mg reduced the total amount of morphine required over 48 hours by 39% relative morphine reduction compared with placebo (P = 0.0001). Pain at rest was reduced by 30% (P = 0.0001). Ninety percent of patients given parecoxib experienced at least 50% maximum total pain relief compared with 58% treated with placebo. The number-needed-to-treat for 1 patient to have at least half pain relief was 3.1 (2.0-4.6). Patients' subjective rating of the medication was described as "excellent, good, and fair" by 48%, 43%, and 8% in the parecoxib group, respectively, compared with 21%, 50%, and 28% of placebo patients (P = 0.004). Overall adverse effects of patients receiving parecoxib and morphine were comparable to those receiving morphine alone. CONCLUSION: The present study demonstrates that the perioperative administration of parecoxib with patient-controlled analgesic morphine after lumber spine surgery resulted in significantly improved postoperative analgesic management as defined by reduction in opioid requirement, lower pain scores, and higher patients' subjective rating of the medication.
Authors: Erik Wang; Dennis Vasquez-Montes; Deeptee Jain; Lorraine H Hutzler; Joseph A Bosco; Themistocles S Protopsaltis; Aaron J Buckland; Charla R Fischer Journal: Int J Spine Surg Date: 2020-12