Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy
Summary
The goal of this clinical trial is to learn if adding a medication called dexmedetomidine to an epidural block works better than a standard epidural to control pain in women undergoing gynecologic laparotomy (abdominal surgery). The main questions it aims to answer are: Does adding dexmedetomidine reduce pain scores and the need for extra pain medicine in the first 24 hours after surgery? Does it lower inflammation levels and reduce the risk of developing chronic pain 3 months later? Participants will receive an epidural (pain medicine delivered through a small tube in the back) combined with general anesthesia for their surgery. Researchers will compare two groups: One group will receive the standard epidural medicine (bupivacaine) mixed with dexmedetomidine. The other group will receive the standard epidural medicine (bupivacaine) alone. Researchers will measure the participants' pain levels, how much pain medicine they use, and blood markers for inflammation for 24 hours after surgery. They will also contact participants 3 months later to check for any long-term pain.
Timeline
- Start
- 2025-08-21
- Primary completion
- 2025-10-15
- Completion
- 2026-01-15
Publications
- Background Gao Y, Chen Z, Huang Y, Sun S, Yang D. Comparison of dexmedetomidine and opioids as local anesthetic adjuvants in patient controlled epidural analgesia: a meta-analysis. Korean J Anesthesiol. 2024 Feb;77(1):139-155. doi: 10.4097/kja.22730. Epub 2023 May 2.
- Background Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.
- Background Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/ml | Other |
| Background | Bupivacaine | Other / unclassified | 0.1 % | Other |