GAP Study: Gabapentin in post surgery pai

Phase 1

• Conditions: Post surgery pain management; MedDRA version: 20.0 Level: LLT Classification code 10036237 Term: Post operative analgesia System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0 Level: PT Classification code 10056350 Term: Pain management System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0 Level: LLT Classification code 10036286 Term: Post-operative pain System Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-002078-38-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

Participant may enter study if ALL of the following apply:

1. Over 18 years of age;
2. Undergoing non-emergency surgery:
- Cardiac (surgery on the heart and great vessels carried out via midline sternotomy);
- Thoracic surgery (open or minimal access surgery on the lungs and surrounding tissues);
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

Exclusion Criteria

Participants may not enter study (i.e. may not be randomised) if ANY of the following apply:

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) <30ml/min/1.732);
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified