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Gabapentin for Pain Management During Dilation and Evacuation

Gabapentin as an Adjunct for Pain Management During Dilation and Evacuation: A Double-blind Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03635905
Acronym
Gabapentin
Enrollment
130
Registered
2018-08-17
Start date
2017-05-26
Completion date
2020-05-20
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

abortion, gabapentin, Neurontin, Dilation and evacuation

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.

Interventions

DRUGGabapentin

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

DRUGPlacebo

Methylcellulose placebo capsule

Sponsors

Society of Family Planning Research Fund
CollaboratorUNKNOWN
Medstar Health Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum procedural painIntra-operativeMeasured on 100-mm visual analog scale (higher score = more pain)

Secondary

MeasureTime frameDescription
NauseaAt enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.Measured on 5-point Likert scale (higher score represents more nausea)
VomitingAt enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.Measured on 5-point Likert scale (higher score represents more vomiting)
AnxietyPrior to procedure and prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure.Measured by State Trait Anxiety Inventory. 20 State anxiety items. Higher score represents more anxiety
Peri-operative painAt enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.Measured by 100-mm visual analog scale (higher score represents more pain)
Adverse eventsRecorded on day of procedure and post-operative day 1Including but not limited to respiratory depression and sedation reversal
IV sedation dosesDay of procedureDoses of IV fentanyl and IV midazolam administered
Satisfaction with pain managementPrior to procedure, prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure, and post-operative day 1Measured on 5-point Likert scale (Higher score represents greater satisfaction)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026