Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College Healthcare NHS Trust
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• All adult patients (18 years and above) who are undergoing either thoracotomy or video assisted thoracic surgery (VATS).

• Participants must be able to understand English.

Exclusion Criteria:

• Patient refusal

• History of previous chronic thoracic pain

• Neuropathic pain (whatever the site), existing at time of recruitment

• Pre-operative analgesic treatments which include the following medications: strong opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin, pregabalin, duloxetine, clonazepam or carbamazepine.

• Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.