Gabapentin in post-surgery pai
- Conditions
- Pain management after surgerySurgery
- Registration Number
- ISRCTN63614165
- Lead Sponsor
- niversity Hospitals Bristol NHS Foundation Trust
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33444208/ protocol (added 15/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1196
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
2. Undergoing non-emergency surgery:
2.1. Cardiac (surgery on the heart and great vessels carried out via midline sternotomy)
2.2. Thoracic surgery (surgery on the lungs and surrounding tissues)
2.3. Abdominal (open or laparoscopic surgery within the abdominal cavity)
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
10. Unwilling to participate in follow-up
11. Prisoners
12. Enrolled in another clinical trial and: a) the patient is currently taking an investigational medicinal product as part of the other trial; or b) co-enrolment is not permitted by the other trial; or c) co-enrolment would be burdensome for the patient
Previous exclusion criteria:
1. Expected to have a minimum length of hospital stay of less than 2 days
2. Taking anti-epileptic medication(s)
3. Allergy to gabapentin
4. Planned epidural analgesia
5. 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)
6. Known renal impairment (for such patients, estimated glomerular filtration rate (eGFR) <30ml/min/1.732)
7. Weight <50kg
8. Inability to provide written informed consent to participate in the trial
9. Unwilling to participate in follow-up
10. Prisoners
11. Already taking gabapentin or gabapentanoids
12. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption
13. Currently taking an investigational medicinal product as part of another clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time from start of surgery to hospital discharge is measured by reviewing participant hospital notes at discharge.
- Secondary Outcome Measures
Name Time Method