Gabapentin for Pain Management During Dilation and Evacuation

NCT03635905 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2017-092
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain

Keywords

abortion; gabapentin; Neurontin; Dilation and evacuation

Outcome Measures

Primary Outcomes (1)

• Maximum procedural pain

  Measured on 100-mm visual analog scale (higher score = more pain)

  Intra-operative

Secondary Outcomes (7)

• Peri-operative pain

  At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.

• Nausea

  At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.

• Vomiting

  At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.

• Anxiety

  Prior to procedure and prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure.

• Satisfaction with pain management

  Prior to procedure, prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure, and post-operative day 1

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin (Neurontin)- 600 mg oral administered pre-operatively at the time of cervical preparation

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gabapentin DRUG

Gabapentin (Neurontin®) is FDA-approved for the treatment of post-herpetic neuralgia and seizure disorder. Off-label uses include chronic refractory cough, neuropathy, hot flashes, restless leg syndrome, social anxiety disorder, and post-operative pain

Also known as: (Neurontin)

Gabapentin

Placebo DRUG

Methylcellulose placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English proficiency
• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Society of Family Planning Research Fund: collaborator

Study Sites (2)

Planned Parenthood

Washington D.C., District of Columbia, 20002, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Brant AR, Reeves MF, Ye PP, Scott RK, Floyd S, Tefera E, Lotke PS. Gabapentin as an adjunct for pain management during dilation and evacuation: A double-blind randomized controlled trial. Contraception. 2023 Feb;118:109892. doi: 10.1016/j.contraception.2022.09.130. Epub 2022 Oct 12.

  PMID: 36243129 DERIVED

MeSH Terms

Conditions

Pain; Dilatation, Pathologic

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 17, 2018
• Study Start: May 26, 2017
• Primary Completion: May 9, 2019
• Study Completion: May 20, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)