A double-blind, randomised placebo-controlled trial to determine whether low-dose intravenous ketamine peri-operatively can prevent chronic post-surgical pain, in patients undergoing thoracotomy or video assisted thoracic surgery (VATS). - RCT of ketamine versus placebo after thoracotomy or VATS surgery (1)

Phase 1

• Conditions: Chronic post-surgical pain

• Registration Number: EUCTR2011-000506-21-GB
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-14
• Study Completion: 2015-07-09
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

1. All adult patients (> 18 years) who are undergoing either thoracotomy or VATS. 2. Participants must be able to understand English.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient refusal 2. History of previous chronic thoracic pain 3. Neuropathic pain (whatever the site), existing at time of recruitment 4. Pre-operative analgesic treatments which include the following medications: strong opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin, pregabalin, duloxetine, clonazepam or carbamazepine. 5. Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of this research is to question whether a low-dose ketamine infusion given for 96 hours during and after surgery, will reduce the incidence of chronic post-surgical pain, 6 weeks after surgery, in patients undergoing thoracotomy and video assisted thoracic surgery (VATS).;Secondary Objective: In addition patients will be interviewed at 3 months, 6 months and one year after surgery, to establish the incidence of chronic post-surgical pain at these time periods. Data will be collected about the amount of opioid (morphine type pain killer) used after surgery to see if this is altered by an infusion of low dose ketamine. The incidence of side-effects will be established.;Primary end point(s): The primary outcome measure will be the difference in pain between the ketamine as placebo groups at 6 weeks following surgery. Pain will be measured using a numeric pain score (NPS), the brief pain inventory (BPI) and the short form Lanss (S-Lanss).