ISRCTN63614165
Active, not recruiting
Phase 4
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)
niversity Hospitals Bristol NHS Foundation Trust0 sites1,196 target enrollmentJune 5, 2017
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pain management after surgery
- Sponsor
- niversity Hospitals Bristol NHS Foundation Trust
- Enrollment
- 1196
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33444208/ protocol (added 15/01/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 18/01/2019:
- •1\. Over 18 years of age
- •2\. Undergoing non\-emergency surgery:
- •2\.1\. Cardiac (surgery on the heart and great vessels carried out via midline sternotomy)
- •2\.2\. Thoracic surgery (open or minimal access surgery on the lungs and surrounding tissues)
- •2\.3\. Abdominal (open or minimal access surgery within the abdominal cavity)
- •3\. Expected to stay in hospital at least until day 2 after surgery (day 0 is day of surgery)
- •4\. Expected to be able to swallow during the time of the study intervention
- •Previous inclusion criteria:
- •1\. Over 18 years of age
Exclusion Criteria
- •Current exclusion criteria as of 18/01/2019:
- •1\. Taking anti\-epileptic medication(s)
- •2\. Allergy to gabapentin
- •3\. Already taking gabapentin or gabapentanoids
- •4\. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption
- •5\. Planned epidural analgesia
- •6\. Intended use of any gabapentanoids in the peri\-operative analgesic protocol other than the study medication (this includes but is not restricted to: pregabalin, enacarbil gabapentin, 4\-methylpregabalin and phenibut)
- •7\. Known renal impairment (for such patients, estimated glomerular filtration rate (eGFR)
- •8\. Weight \<50kg
- •9\. Inability to provide written informed consent to participate in the trial
Outcomes
Primary Outcomes
Not specified
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