Gabapentin for Pain Management During Dilation and Evacuation

NCT ID: NCT03635905

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-26
• Study Completion Date: 2020-05-20

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.

Detailed Description

Over 900,000 abortion procedures are performed annually in the United States [1]. For many women, pain relief during abortion is inadequate despite the use of non-steroidal anti-inflammatory drugs, local anesthetics, opioids, and/or moderate sedation. Research on pain control during abortion has focused on methods for relief during first-trimester suction curettage with little research dedicated to pain during dilation and evacuation (D&E). Gabapentin (Neurontin) has emerged as an effective adjunct to pain management for a variety of surgical procedures. Gabapentin is inexpensive and is also effective in reducing anxiety, nausea, and vomiting. The addition of pre-operative gabapentin to moderate sedation during D&E may lead to increased patient satisfaction and pain relief without significantly increasing risk or cost.

Proposed Research. 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. The investigators hypothesize that the doses of moderate sedation agents required to obtain adequate sedation will be decreased if participants receive gabapentin, versus placebo. The investigators also plan to compare the risk of adverse events with adjunct gabapentin versus placebo with moderate sedation.

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. Baseline characteristics will be recorded. Pain will be assessed pre-operatively, at 3 intraoperative time points, and postoperatively by 100 mm visual analog scale (VAS). The investigators plan to assess satisfaction with pain control, nausea, vomiting, and anxiety preoperatively and post-operatively, using 5-point Likert scales and the State Trait Anxiety Inventory, respectively. A final assessment will be made by phone on post-operative day one to evaluate overall satisfaction and perform a final screen for adverse events.

New features. No publications have evaluated the use of gabapentin during abortion care, although multiple studies are currently underway investigating gabapentin's effects during first trimester abortion and during overnight cervical osmotic dilators. To the investigators knowledge, this will be the first evaluation of gabapentin in conjunction with moderate sedation for pain relief during same-day second trimester abortion.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gabapentin

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

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: 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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Methylcellulose placebo capsule

Interventions

Gabapentin

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

Intervention Type: DRUG

Placebo

Methylcellulose placebo capsule

Intervention Type: DRUG

Other Intervention Names

(Neurontin)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning Research Fund

UNKNOWN

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Pamela Lotke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Planned Parenthood

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

MedStar Washington Hospital Center

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36243129 (View on PubMed)

Other Identifiers

2017-092

Identifier Type: -

Identifier Source: org_study_id