PMID- 32511143 OWN - NLM STAT- MEDLINE DCOM- 20210524 LR - 20221005 IS - 1528-1132 (Electronic) IS - 0009-921X (Print) IS - 0009-921X (Linking) VI - 478 IP - 12 DP - 2020 Dec TI - No Difference in Pain After Spine Surgery with Local Wound Filtration of Morphine and Ketorolac: A Randomized Controlled Trial. PG - 2823-2829 LID - 10.1097/CORR.0000000000001354 [doi] AB - BACKGROUND: Controlling postoperative pain after spinal surgery is important for rehabilitation and patient satisfaction. Wound infiltration with local anesthetics may improve postoperative pain, but true multimodal approaches for achieving analgesia after spinal surgery remain unknown. QUESTIONS/PURPOSES: In this randomized, controlled, double-blind trial after lumbar interbody fusion, we asked: (1) Does multimodal analgesia reduce VAS pain scores by a clinically important amount? (2) Does this analgesic approach reduce the amount of morphine patients consume after surgery? (3) Is this approach associated with fewer opioid-related side effects after surgery? METHODS: This study included 80 adult patients undergoing lumbar interbody fusion who were randomized into two groups: A control group (n = 40) who received infiltration of the surgical incision at the end of the procedure with an injection of 0.5% bupivacaine 100 mg (20 mL) and epinephrine 0.5 mg (0.5 mL), and the multimodal group (n = 40), who received wound infiltration with the same approach but with different medications: 0.5% bupivacaine 92.5 mg (18.5 mL), ketorolac 30 mg (1 mL), morphine 5 mg (0.5 mL), and epinephrine 0.5 mg (0.5 mL). There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time. All treatments were administered by one surgeon. All patients, the surgeon, and the researchers were blinded to the allocation of patients to each group. Pain at rest was recorded using the VAS. Postoperative morphine consumption (administered using a patient-controlled analgesia pump) and opiod-associated side effects including nausea/vomiting, pruritus, urinary retention, and respiratory depression were assessed; this study was analyzed according to intention-to-treat principles. No loss to follow-up or protocol deviations were noted. We considered a 2-cm change on a 10-cm scale on the VAS as the minimum clinically important difference (MCID). Differences smaller than this were considered unlikely to be important. RESULTS: At no point were there between-group differences in the VAS scores that exceeded the MCID, indicating no clinically important reductions in pain associated with administering multimodal injections. The highest treatment effect was observed at 3 hours that showed only a -1.3 cm mean difference between the multimodal and the control groups (3.2 +/- 1.8 versus 4.5 +/- 1.9 [95% CI -1.3 to -0.3]; p < 0.001), which was below the MCID. Morphine consumption was very slightly higher in the control group than in the multimodal group (2.8 +/- 2.8 versus 0.3 +/- 1.0, mean difference 2.47; p < 0.001). The percentage of patients reporting opioid-related side effects was lower in the multimodal group than in the control group. The proportions of nausea and vomiting were higher in the control group (30% [12 of 40] than in the multimodal group (3% [1 of 40]; p = 0.001). All of these side effects were transient and none was severe. CONCLUSIONS: Multimodal wound infiltration with an NSAID and morphine did not yield any clinically important reduction in pain or opioid consumption. Since no substantial benefit of adding these drugs to a patient's aftercare regimen was achieved, and considering the potential risks of administering opioids and NSAIDs (such as, polypharmacy in older patients, serious adverse effects of NSAIDs), we recommend against routine use of this approach in clinical practice. LEVEL OF EVIDENCE: Level I, therapeutic study. FAU - Singhatanadgige, Weerasak AU - Singhatanadgige W AD - W. Singhatanadgige, T. Chancharoenchai, C. Tanavalee, W. Limthongkul, Department of Orthopedic Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. FAU - Chancharoenchai, Todsapon AU - Chancharoenchai T AD - W. Singhatanadgige, T. Chancharoenchai, C. Tanavalee, W. Limthongkul, Department of Orthopedic Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. FAU - Honsawek, Sittisak AU - Honsawek S AD - S. Honsawek, Osteoarthritis and Musculoskeleton Research Unit, Department of Biochemistry, Faculty of Medicine, KingChulalongkorn Memorial Hospital, Thai Red Cross Society, Chulalongkorn University, Bangkok, Thailand. FAU - Kotheeranurak, Vit AU - Kotheeranurak V AD - V. Kotheeranurak, Spine Unit, Department of Orthopaedics, Queen Savang Vadhana Memorial Hospital, Sriracha, Chonburi, Thailand. FAU - Tanavalee, Chotetawan AU - Tanavalee C AD - W. Singhatanadgige, T. Chancharoenchai, C. Tanavalee, W. Limthongkul, Department of Orthopedic Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. FAU - Limthongkul, Worawat AU - Limthongkul W AD - W. Singhatanadgige, T. Chancharoenchai, C. Tanavalee, W. Limthongkul, Department of Orthopedic Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Clin Orthop Relat Res JT - Clinical orthopaedics and related research JID - 0075674 RN - 0 (Analgesics, Opioid) RN - 0 (Anesthetics, Local) RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 76I7G6D29C (Morphine) RN - Y8335394RO (Bupivacaine) RN - YZI5105V0L (Ketorolac) SB - IM CIN - Clin Orthop Relat Res. 2020 Dec;478(12):2830-2832. PMID: 32667750 MH - Aged MH - Analgesics, Opioid/*administration & dosage/adverse effects MH - Anesthetics, Local/administration & dosage MH - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects MH - Bupivacaine/administration & dosage MH - Double-Blind Method MH - Drug Therapy, Combination MH - Female MH - Humans MH - Ketorolac/*administration & dosage/adverse effects MH - Lumbar Vertebrae/*surgery MH - Male MH - Middle Aged MH - Morphine/*administration & dosage/adverse effects MH - Pain Measurement MH - Pain, Postoperative/diagnosis/etiology/*prevention & control MH - *Spinal Fusion/adverse effects MH - Thailand MH - Time Factors MH - Treatment Outcome PMC - PMC7899384 COIS- Each author certifies that neither he or she, nor any member of his or her immediate family, has funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research(R) editors and board members are on file with the publication and can be viewed on request. EDAT- 2020/06/09 06:00 MHDA- 2021/05/25 06:00 PMCR- 2021/12/01 CRDT- 2020/06/09 06:00 PHST- 2020/06/09 06:00 [pubmed] PHST- 2021/05/25 06:00 [medline] PHST- 2020/06/09 06:00 [entrez] PHST- 2021/12/01 00:00 [pmc-release] AID - 00003086-202012000-00024 [pii] AID - CORR-D-20-00006 [pii] AID - 10.1097/CORR.0000000000001354 [doi] PST - ppublish SO - Clin Orthop Relat Res. 2020 Dec;478(12):2823-2829. doi: 10.1097/CORR.0000000000001354.