Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-06-14

Brief Summary

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This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.

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Detailed Description

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Conditions

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Other Abortion Spontaneous Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: Placebo

Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure

Group 2: Gabapentin

Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

600mg Gabapentin administered orally 1-2 hours prior to procedure

Interventions

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Gabapentin

600mg Gabapentin administered orally 1-2 hours prior to procedure

Intervention Type DRUG

Placebo

Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure

Intervention Type DRUG

Other Intervention Names

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Neurontin sugar pill

Eligibility Criteria

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Inclusion Criteria

* Women \>=18 years-old
* Presenting for a surgical abortion
* No contraindication to outpatient abortion
* No contraindication to gabapentin
* Fluency in English and able to provide informed consent