RCT of ketamine versus placebo after thoracotomy or VATS surgery (1)
Research type
Research Study
Full title
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).
IRAS ID
57708
Eudract number
2011-000506-21
Clinicaltrials.gov Identifier
Research summary
This study will investigate whether an infusion of low-dose ketamine, given to patients following thoracotomy or video assisted thoracic surgery (VATS), will reduce the incidence of chronic pain after surgery. A recent study reported that 40% patients experienced chronic pain, one year after thoracic surgery. It is thought that chronic post-surgical pain develops when the normally dormant, N-methyl-D-aspartate (NMDA) receptor, is activated in the dorsal horn of the spinal cord. This receptor is activated when pain is uncontrolled after surgery. Once activated pain becomes persistent. Ketamine blocks the NMDA receptor, thereby preventing chronic post-surgical pain. All patients will receive standard post-operative pain management following thoracic surgery. Patients will be randomised to receive either an intravenous infusion of ketamine or saline (placebo); patients, medical staff and investigators will be blinded to the treatment the patient has received. The infusion will start 10 minutes before surgery and will last for 96 hours.Patients who consent to participate will be asked to complete standard pain questionnaires, such as the Brief Pain Inventory [BPI], short form Leeds Assessment of Neuropathic Symptoms and Signs [S-LANSS]) prior to surgery, then at 6 weeks, 3, 6 and 12 months after surgery. The surgical area will also be examined at 6 weeks, 6 and 12 months for signs of neuropathic or nerve pain. Whilst in hospital, patients will be asked to score their pain daily on a numeric pain scale of 0 to 10. Consumption of morphine and side-effects will be recorded.Patients will be excluded from the study if they do not wish to take part, if they have neuropathic pain, or are taking medications to treat chronic pain prior to surgery.Patients will be recruited at Imperial College Healthcare NHS Trust. This research is funded by the National Institute for Health Research (NIHR).
REC name
London - South East Research Ethics Committee
REC reference
11/LO/0387
Date of REC Opinion
21 Jun 2011
REC opinion
Further Information Favourable Opinion