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

Denver Health and Hospital Authority

Status and phase: Completed; Early Phase 1

Conditions: Acute Pain

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT02856750

16-1170

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

gabapentin

Experimental group

Description:

gabapentin 300 mg three times daily x 30 d

Treatment:

Drug: Gabapentin

placebo

No Intervention group

Description:

no gabapentin administered to this arm.