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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856750
• Other study ID #: 16-1170
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2016
• Est. completion date: October 23, 2018

Study information

• Verified date: October 2018
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 23, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Rib Fractures

Intervention

Drug:
• Gabapentin
Gabapentin 300 mg three times daily x30 days

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

Sirmali M, Türüt H, Topçu S, Gülhan 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Narcotic requirements	measurement of daily narcotic use as 24 hour requirements of morphine equivalents, and duration of narcotic needs.	30 days
Secondary	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