Gabapentin for Pain Management During Dilation and Evacuation

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain

In brief

Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D\&E. To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation.

Key facts

Study ID: NCT03635905
Run by: Medstar Health Research Institute
People needed: 130
Starts: 2017-05-26
Expected to finish: 2020-05-20
Last updated by the study team: 2020-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

English proficiency
18 years of age or older
Gestational age 14 weeks or greater
Ability to provide informed consent
Desire to proceed with outpatient D\&E under moderate sedation

You may not qualify if…

Contraindications to outpatient abortion or moderate sedation
Current use of gabapentin (Neurontin®) or pregabalin (Lyrica®)
Severe renal disease
Allergy or sensitivity to gabapentin or pregabalin

Where it is running

Planned Parenthood — Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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