Phase 4
Completed N=109
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy
Source: ClinicalTrials.gov NCT02359110 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: NRS (Numerical Rating Scale) — 3.5; 3.4; 5.4; 5.5 units on a scale — p=0.89
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NRS (Numerical Rating Scale) |
3.5; 3.4; 5.4; 5.5; 5.3; 5.8 | 0.89 |
| SECONDARY VAS (Visual Analog Scale) |
37.8; 33.9; 38.7; 36.9 | 0.52 |
| SECONDARY Total Morphine Consumption |
14.3; 14.7 | 0.88 |
Eligibility Criteria
Inclusion Criteria
- The patient must be female and planning to have a laparoscopic or robotic assisted procedure for benign gynecologic indications.
- Patients must be treated in the department of Obstetrics and Gynecology in the division of Minimally Invasive Gynecologic Surgery.
- The patient must be in the age range of 18-80 years, in general good health and able to comply with study procedures.
Exclusion Criteria
- Male patients will be excluded from this study.
- Patients under 18 years old will be excluded from this study.
- Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude pregnancy.
- Patients having abdominal, vaginal or hysteroscopic procedures
- Allergy to gabapentin
- Chronic use of gabapentin (greater than 6 months)
Data sourced from ClinicalTrials.gov (NCT02359110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.