Clinical trial NCT02856750: Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
Official title: A Multicenter, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Pain
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2016-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Daily Pain Score
timeFrame: 30 days
Secondary outcomes:
measure: Narcotic requirements
timeFrame: 30 days
measure: pulmonary function
timeFrame: 30 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health
name: Fredric M Pieracci, MD, PMPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.