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
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.
Summary of Results:
Background: Gabapentin is a medicine used to treat epilepsy and pain caused by damaged nerves. Doctors have recently been using gabapentin to treat pain after an operation, with the intention of reducing the amount of morphine type drugs (called “opioids”) needed while maintaining good pain relief. Doctors want to try to reduce the amount of opioid drugs because they cause side-effects (such as dizziness and reduced breathing rate), often delaying discharge from hospital and leading to slower recovery. There is uncertainty about whether adding gabapentin to the usual painkilling drugs will result in good pain relief, with fewer side effects, and therefore faster recovery after surgery.
Who participated? 1195 adults having major heart, lung or abdominal surgery who were expected to stay in hospital for at least 2-days after their surgery.
What was involved? The participants were either given gabapentin or placebo (the same tablet but with no active drug) just before and twice daily for 2-days after their surgery. We measured how long they stayed in hospital after the surgery, the amount of opioid drugs they used, the amount of pain they had, what their quality-of-life was and how much they cost associated with providing their care within the NHS. We measured these during their hospital stay and at 4-weeks and 4-months after the surgery.
What did the trial find? The trial found that there was no difference in the length of hospital stay, the number of adverse health events, or NHS costs between people who took gabapentin and those who took the placebo. People who took gabapentin for abdominal and thoracic surgery used fewer opioid-type drugs in-hospital after their surgery – but this did not translate into better pain control or fewer side-effects. Therefore, this trial tells us that doctors should stop routinely giving gabapentin to people to reduce their pain after major surgery.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