GAP Study: Gabapentin in Post Surgery Pain
Research type
Research Study
Full title
Effectiveness, cost effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: A placebo controlled randomised controlled trial with blinding (The GAP study)
IRAS ID
225986
Contact name
Ben Gibbison
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Eudract number
2017-002078-38
ISRCTN Number
ISRCTN63614165
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Gabapentin is a medicine used to treat epilepsy and pain caused by dysfunctional nerves. Recently, doctors have begun using gabapentin to treat pain after an operation, with the intention of reducing the amount of other drugs needed while maintaining good pain relief. Opioid drugs (for example morphine and fentanyl) are the most commonly used drugs to control pain after surgery, but doctors want to try to reduce the amount of opioid drugs because they cause side effects, often delaying discharge from hospital and leading to slower recovery. There is uncertainty about whether adding gabapentin to the usual drug regimen (which includes opioid drugs) will result in good pain relief, fewer side effects overall and faster recovery after surgery.
We want to conduct a randomised controlled trial, in which patients undergoing different types of surgery (heart, lungs or abdominal) are allocated by chance to receive gabapentin or an identical looking dummy pill (known as a placebo) in addition to the usual painkillers for each type of surgery. We will give patients gabapentin or placebo one hour before surgery and for two days after surgery. Every other aspect of care will stay the same. We will then compare patients who received gabapentin with those who received the placebo to determine whether gabapentin reduces the amount of time patients stay in hospital after the operation, the amount of other pain medication they take, and to assess how gabapentin influences pain in hospital and four months after surgery. A health economic analysis will determine whether using gabapentin provides better health outcomes for patients undergoing surgery and is cost-effective for the NHS relative to current standard care.Phase 1 will determine whether we can recruit patients and whether patients take gabapentin/placebo as instructed. Recruitment will continue in phase 2 until 1500 patients are recruited.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0381
Date of REC Opinion
24 Nov 2017
REC opinion
Further Information Favourable Opinion