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Completed

NCT Number: NCT02725710

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

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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Key information

Conditions

Other Abortion Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Spontaneous Abortion Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

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

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

Exclusion criteria

  • Allergy, sensitivity or contraindication to gabapentin
  • Severe renal disease
  • Currently using gabapentin or pregalabin

Treatment and study plan

Gabapentin

Drug

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

Other names: Neurontin

Placebo

Drug

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

Other names: sugar pill

Primary outcomes

  1. Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure

    Time frame: 5 minutes

    Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.

Secondary outcomes

  1. Pain Score on the 100-mm VAS

    Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute

    Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.

  2. Perioperative Nausea as Measured by 100-mm VAS

    Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

    Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.

  3. Number of Subjects Experiencing Perioperative Vomiting

    Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

  4. Perioperative Anxiety as Measured by the 100-mm VAS

    Time frame: 5 minutes, 10 minutes, 30 minutes, discharge

    Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.

  5. Number of Subjects Using Pain Medications

    Time frame: 24 hours post-operatively

    Pain medications included ibuprofen and oxycodone.

  6. Number of Subjects Experiencing Side Effects

    Time frame: 10 minutes post-procedure

    Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.

  7. Pain (on a 5-point Scale)

    Time frame: Post-operative day 1

  8. Nausea (on a 5-point Scale)

    Time frame: Post-operative day 1

  9. Vomiting (on a 5-point Scale)

    Time frame: Post-operative day 1

  10. Side Effects (on a 5-point Scale)

    Time frame: Post-operative day 1

  11. General Satisfaction With the Procedure (on a 5-point Scale)

    Time frame: Post-operative day 1

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial

Acronym: GABA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 1, 2016
Registry last updated
Jul 2, 2019

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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