Phase 4
N=125
Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
Post Operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT02285010 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Post Operative Morphine Consumption — 1; 0; 1; 1 mg — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- placebo (Drug); Pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mahidol University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Morphine Consumption |
1; 0; 1; 1; 4; 5 | 0.60 |
| SECONDARY Time to First Analgesia |
4.6; 7.7 | 0.10 |
| SECONDARY Pain Scores on the Visual Analog Scale |
2; 2; 4; 4 | 0.33 |
| SECONDARY Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability |
7; 17; 35; 31; 15; 10 | 0.16 |
| SECONDARY Number of Patients Evaluating Their Satisfaction |
0; 0; 1; 5; 19; 25 | 0.05 |
Summary
This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.
Eligibility Criteria
Inclusion Criteria
- ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
- Patient can use patient-controlled analgesia (IV PCA)
Exclusion Criteria
- History of drug allergy to gabapentinoid and related drug
- History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
- Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and Psychiatric disorder
Data sourced from ClinicalTrials.gov (NCT02285010). 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.