Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery

Summary

Patients undergoing major spinal surgery usually experience moderate-to-severe postoperative pain. Inadequate pain control may lead to severe complications. Dexamethasone as an adjunctive infiltration to local anesthesia (LA) presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. Compared with dexamethasone, dexamethasone palmitate emulsion (DXP) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. To date, no studies have evaluated the additive analgesia effects of DXP on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of DXP emulsion and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.

Timeline

Start

2023-03-01

Primary completion

2023-06-30

Completion

2023-09-30

Publications

• Background Lamperti M, Tufegdzic B, Avitsian R. Management of complex spine surgery. Curr Opin Anaesthesiol. 2017 Oct;30(5):551-556. doi: 10.1097/ACO.0000000000000494.
• Background Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.
• Background Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.
• Background Shrestha N, Han B, Wang X, Jia W, Luo F. Methylprednisolone as an Adjunct to Local Infiltration on Laminoplasty or Laminectomy before Wound Closure: A Randomized Controlled Trial. Pain Res Manag. 2022 Aug 3;2022:2274934. doi: 10.1155/2022/2274934. eCollection 2022.
• Background Ye X, Ren YF, Hu YC, Tan SY, Jiang H, Zhang LF, Shi W, Wang YT. Dexamethasone Does Not Provide Additional Clinical Analgesia Effect to Local Wound Infiltration: A Comprehensive Systematic Review and Meta-Analysis. Adv Wound Care (New Rochelle). 2023 Jan;12(1):1-14. doi: 10.1089/wound.2021.0163. Epub 2022 Mar 1.
• Background Zhao C, Wang S, Pan Y, Ji N, Luo F. Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial. J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.
• Background Han X, Ren T, Wang Y, Ji N, Luo F. Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1253-1261. doi: 10.1213/ANE.0000000000005971. Epub 2022 Mar 21.
• Yu B, Wang B, Shrestha N, Luo F. Pre-emptive coinfiltration of dexamethasone palmitate emulsion with ropivacaine for postoperative pain in patients undergoing major spine surgery: a study protocol for a prospective, randomised controlled, multicentre trial. BMJ Open. 2023 May 24;13(5):e072162. doi: 10.1136/bmjopen-2023-072162.

Drugs

Indications

No indication recorded.