Phase 2
N=95
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration
Other Abortion · Spontaneous Abortion
Bottom Line
View on ClinicalTrials.gov: NCT02725710 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure — 35.7; 37.1 score on a scale — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gabapentin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure |
35.7; 37.1 | 0.56 |
| SECONDARY Pain Score on the 100-mm VAS |
3.3; 3.0; 19.8; 20.0; 12.6; 9.5 | — |
| SECONDARY Perioperative Nausea as Measured by 100-mm VAS |
3.0; 3.0; 2.5; 1.0; 2.3; 1.0 | — |
| SECONDARY Number of Subjects Experiencing Perioperative Vomiting |
1; 0; 1; 2; 1; 5 | — |
| SECONDARY Perioperative Anxiety as Measured by the 100-mm VAS |
24.5; 23.5; 14.5; 11.0; 13.3; 7.0 | — |
| SECONDARY Number of Subjects Using Pain Medications |
10; 17; 23; 23; 9; 6 | — |
| SECONDARY Number of Subjects Experiencing Side Effects |
14; 20; 8; 6; 37; 41 | — |
| SECONDARY Pain (on a 5-point Scale) |
— | — |
| SECONDARY Nausea (on a 5-point Scale) |
— | — |
| SECONDARY Vomiting (on a 5-point Scale) |
— | — |
| SECONDARY Side Effects (on a 5-point Scale) |
— | — |
| SECONDARY General Satisfaction With the Procedure (on a 5-point Scale) |
— | — |
Summary
This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.
Eligibility Criteria
Inclusion Criteria
- Women >=18 years-old
- Presenting for a surgical abortion
- No contraindication to outpatient abortion
- No contraindication to gabapentin
- Fluency in English and able to provide informed consent
Exclusion Criteria
- Allergy, sensitivity or contraindication to gabapentin
- Severe renal disease
- Currently using gabapentin or pregalabin
Data sourced from ClinicalTrials.gov (NCT02725710). 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.