Phase 4
N=114
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02944656 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Pain at Time of Uterine Evacuation — 63.79; 62.21; 64.58; 66.12 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain at Time of Uterine Evacuation |
63.79; 62.21; 64.58; 66.12; 67.77; 71.06 | — |
| SECONDARY Perioperative Pain Level |
20.76; 22.48; 44.10; 47.61; 30.64; 43.68 | — |
| SECONDARY Number of Participants Using Pain Medication |
24; 27 | — |
| SECONDARY Perioperative Nausea |
26; 26; 1; 12; 0; 5 | — |
| SECONDARY Perioperative Vomiting |
4; 7; 5; 2; 5; 5 | — |
| SECONDARY Anxiety Levels |
66; 72; 14; 17; 4; 2 | — |
| SECONDARY Side Effects |
27; 23; 19; 15; 9; 9 | — |
| SECONDARY Moderate Pain at Postoperation Follow-up Assessment |
5.2; 5.2 | — |
| SECONDARY Severe Pain at Postoperation Follow-up Assessment |
3.5; 3.2 | — |
| SECONDARY Nausea or Vomiting at Postoperation Follow-up Assessment |
2.3; 3.2 | — |
| SECONDARY Vomiting Since Leaving Clinic |
46; 45; 1; 2 | — |
| SECONDARY Overall Satisfaction With the Procedure |
0; 1; 0; 0; 0; 2 | — |
Summary
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.
Eligibility Criteria
Inclusion Criteria
- Women >=18 years-old
- Presenting for a surgical abortion
- Fluency in English and able to provide informed consent
- Has a driver to take them home following the procedure
Exclusion Criteria
- Allergy, sensitivity or contraindication to gabapentin
- Severe renal disease
- Currently using gabapentin or pregabalin
- Contraindication to outpatient abortion under local anesthesia
Data sourced from ClinicalTrials.gov (NCT02944656). 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.