drugset / Trial / NCT02703259
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of the investigators' study is to assess the efficacy of a single dose of preoperative gabapentin within an enhanced recovery after surgery protocol in acute postoperative pain reduction for women undergoing a minimally invasive hysterectomy. Participants who consent to participate will be randomized to either a control group without gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery. The investigators will collect data on postoperative narcotic use, subjective pain as rated by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.
Timeline
- Start
- 2016-06
- Primary completion
- 2017-07
- Completion
- 2017-07
Publications
- Background Alayed N, Alghanaim N, Tan X, Tulandi T. Preemptive use of gabapentin in abdominal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jun;123(6):1221-1229. doi: 10.1097/AOG.0000000000000289.
- Background Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J. The prevention of chronic postsurgical pain using gabapentin and pregabalin: a combined systematic review and meta-analysis. Anesth Analg. 2012 Aug;115(2):428-42. doi: 10.1213/ANE.0b013e318249d36e. Epub 2012 Mar 13.
- Background Dolin SJ, Cashman JN. Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data. Br J Anaesth. 2005 Nov;95(5):584-91. doi: 10.1093/bja/aei227. Epub 2005 Sep 16.
- Background Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. No abstract available.
- Background Straube S, Derry S, Moore RA, Wiffen PJ, McQuay HJ. Single dose oral gabapentin for established acute postoperative pain in adults. Cochrane Database Syst Rev. 2010 May 12;(5):CD008183. doi: 10.1002/14651858.CD008183.pub2.
- Background Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
- Huynh TQ, Patel NR, Goldstein ND, Makai GE. Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):237-244.e2. doi: 10.1016/j.jmig.2020.04.040. Epub 2020 May 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gabapentin | Small molecule | 600 mg | Oral |
| Comparator | Acetaminophen | Small molecule | 975 mg | Oral |
| Comparator | Celecoxib | Other / unclassified | 400 mg | Oral |
Indications
No indication recorded.