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Completed

NCT Number: NCT02856750

Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures

A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjutant Pain Control Following Acute Rib Fractures.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

About this study

Traumatic rib fractures are a tremendous source of pain which can limit respiratory function and overall recovery. Numerous multimodal pain management strategies have been employed with varying success; however, narcotics remain the mainstay of treatment. Beyond the acute side effects of narcotics, including altered mental status, depression of respiratory drive, and constipation, there is a substantial risk of long term dependency. Recently, loco-regional blockade and non-narcotic adjuncts have received increasing support within the literature. Gabapentin has been used extensively as a non-narcotic adjunct to analgesia regimens in the acute and chronic settings, however its ability to better control pain secondary to traumatic rib fractures has never been studied .

The primary aim is to assess the efficacy of gabapentin as an analgesic after rib fractures. Secondary aims are to assess the effect on pulmonary function and other known complications following rib fractures.

The hypothesis is gabapentin will improve pain control as measured by lower pain scores and lower narcotic needs. The investigators plan to test this hypothesis by recruiting trauma patients with rib fractures, and randomly assign them to gabapentin versus a placebo.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • > 1 rib fractures
  • Requiring hospital admission
  • Enrolled within 24 hours of injury

Exclusion criteria

  • Pregnancy
  • Intubation
  • Age <18, age >65
  • Inability to tolerate PO medication
  • Patient refusal
  • Inability to obtain consent from patient or surrogate
  • Renal or Hepatic impairment
  • Allergy or Hypersensitivity to gabapentin or any component of the formulation

Treatment and study plan

Gabapentin

Drug

Gabapentin 300 mg three times daily x30 days

Other names: neurontin

Primary outcomes

  1. Average Daily Pain Score

    Time frame: 30 days

    the pain score uses the visual analog scale and ranges from 0 to 10. This is recorded by nursing at pre-specified intervals depending on level of care.

Secondary outcomes

  1. Narcotic requirements

    Time frame: 30 days

    measurement of daily narcotic use as 24 hour requirements of morphine equivalents, and duration of narcotic needs.

  2. pulmonary function

    Time frame: 30 days

    assessment of the incidence of pneumonia (defined clinically by the treatment team), the incidence of hypoxemia, as well as readmission for pulmonary compromise.

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • University of Colorado, Denver

Registry information

Official study title

A Multicenter, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2016
Registry last updated
Oct 26, 2018

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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