Pain management after surgery Surgery Pain management after surgery
Conditions
Interventions
Participants are randomised in a 1:1 ratio to one of two groups by an authorised member of the local research team using a secure internet-based randomisation system ensuring allocation concealment.
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion 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 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)
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from start of surgery to hospital discharge is measured by reviewing participant hospital notes at discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Opioid consumption in the period from surgery until hospital discharge is measured by reviewing participant hospital notes at hospital discharge 2. Acute post-operative pain is assessed using the visual analogue scale (VAS) completed at 1, 4 and 12 hours post-surgery and then twice daily to discharge 3. Adverse health events from randomisation to 4 months including side effects of medication (e.g. nausea; vomiting; pruritus; sedation; confusion) and on-going pain are assessed by reviewing participant hospital notes throughout their hospital stay and at discharge, as well as phone calls with the participants at 4 weeks and 4 months after randomisation 4. HRQoL measured using the EQ-5D 5 level questionnaire and Short-form (SF) 12 completed at baseline and at follow-up at approximately 4 weeks and 4 months after randomisation 5. Resource use to 4 months is measured by reviewing participant hospital notes and completion of Resource Use Questionnaires during the hospital stay, at 4 weeks and 4 months 6. Chronic pain is measured using the brief pain inventory (BPI) at baseline and at 4 months after randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed