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

A Multicenter, Randomized Controlled Trial of the 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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Gabapentin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gabapentin; gabapentin 300 mg three times daily x 30 d	Drug: Gabapentin; Gabapentin 300 mg three times daily x30 days; Other Names: neurontin
No Intervention: placebo; no gabapentin administered to this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Pain Score	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic requirements	measurement of daily narcotic use as 24 hour requirements of morphine equivalents, and duration of narcotic needs.	30 days
pulmonary function	assessment of the incidence of pneumonia (defined clinically by the treatment team), the incidence of hypoxemia, as well as readmission for pulmonary compromise.	30 days

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Fredric M Pieracci, MD, PMPH, Denver Health

Publications and helpful links

General Publications

• Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2.
• Chapman BC, Herbert B, Rodil M, Salotto J, Stovall RT, Biffl W, Johnson J, Burlew CC, Barnett C, Fox C, Moore EE, Jurkovich GJ, Pieracci FM. RibScore: A novel radiographic score based on fracture pattern that predicts pneumonia, respiratory failure, and tracheostomy. J Trauma Acute Care Surg. 2016 Jan;80(1):95-101. doi: 10.1097/TA.0000000000000867.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): October 23, 2018
• Study Completion (Actual): October 23, 2018

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Acute Pain; Rib Fractures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 16-1170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No