Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
Primary Purpose
Acute Pain
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
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
Sites / Locations
- Denver Health Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
gabapentin
placebo
Arm Description
gabapentin 300 mg three times daily x 30 d
no gabapentin administered to this arm.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Narcotic requirements
measurement of daily narcotic use as 24 hour requirements of morphine equivalents, and duration of narcotic needs.
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.
Full Information
NCT ID
NCT02856750
First Posted
July 15, 2016
Last Updated
October 24, 2018
Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02856750
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gabapentin
Arm Type
Experimental
Arm Description
gabapentin 300 mg three times daily x 30 d
Arm Title
placebo
Arm Type
No Intervention
Arm Description
no gabapentin administered to this arm.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
neurontin
Intervention Description
Gabapentin 300 mg three times daily x30 days
Primary Outcome Measure Information:
Title
Average Daily Pain Score
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Narcotic requirements
Description
measurement of daily narcotic use as 24 hour requirements of morphine equivalents, and duration of narcotic needs.
Time Frame
30 days
Title
pulmonary function
Description
assessment of the incidence of pneumonia (defined clinically by the treatment team), the incidence of hypoxemia, as well as readmission for pulmonary compromise.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredric M Pieracci, MD, PMPH
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12853057
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.
Results Reference
background
PubMed Identifier
26683395
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.
Results Reference
background
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Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
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