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Completed

NCT Number: NCT04292171

Gabapentin for Perioperative Pain Relief in Surgical Abortion

Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.

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Key information

Conditions

Pain Control Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Birth Control Care Center

Las Vegas, Nevada, 89104, United States

About this study

A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age.
  • English or Spanish speaking
  • eligible for office-based surgical pregnancy termination

Exclusion criteria

  • present use of gabapentin or pregabalin,
  • renal disease
  • sensitivity or allergy to gabapentin
  • Missed abortion

Treatment and study plan

Gabapentin

Drug

Preoperative treatment with Gabapentin

Placebos

Drug

Preoperative treatment with Placebo

Primary outcomes

  1. Pain Score

    Time frame: 5 minutes postoperative

    100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain

Secondary outcomes

  1. Pain Score 24

    Time frame: 24 hours postop

    Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain

  2. Nausea

    Time frame: 24 hours postoperative

    Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme

  3. Vomiting

    Time frame: 24 hours postoperative

    Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme

  4. Pain Score at 30 Minutes Postoperative

    Time frame: 30 minutes postoperative

    100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Official study title

Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2020
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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