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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-10-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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gabapentin

gabapentin 300 mg three times daily x 30 d

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 300 mg three times daily x30 days

placebo

no gabapentin administered to this arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gabapentin

Gabapentin 300 mg three times daily x30 days

Intervention Type DRUG

Other Intervention Names

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neurontin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes