Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention
Summary
This study will test the null hypothesis that low-dose ketamine given peri-operatively will have no effect on the development of chronic post-surgical pain, in patients undergoing thoracotomy or video assisted thoracic surgery (VATS) procedures A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis. Potential participants due to undergo either thoracotomy or video assisted thoracic surgery (VATS) will be identified by the collaborating thoracic surgeons in the out-patient department. Patients will be sent information about the study by post, prior to admission for surgery. If they are willing to participate, written consent will be sought on the ward preoperatively, where they will complete baseline measures of pain. Patients will be randomised to receive an intravenous infusion of placebo (saline) or ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and continuing for the first three postoperative days (96 hours in total). Prior to starting the infusion a loading dose of ketamine (0.1 mg per kg) will be administered.
Timeline
- Start
- 2011-04
- Primary completion
- 2015-07
- Completion
- 2015-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Saline vs Ketamine; p = 0.33; Wilcoxon (Mann-Whitney) NCT01296347 ↗
paper There were no differences in pain measures or opioid consumption at 6 weeks, 3, 6 or 12 months. PMID 30719817 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 0.1 mg/kg | Intravenous |