Denver Health Medical Center
Denver, Colorado, 80204, United States
NCT Number: NCT02856750
A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjutant Pain Control Following Acute Rib Fractures.
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Notify Me18 year–65 year
All sexes
Interventional
Early Phase 1
Denver, Colorado, 80204, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gabapentin 300 mg three times daily x30 days
Other names: neurontin
Time frame: 30 days
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
measurement of daily narcotic use as 24 hour requirements of morphine equivalents, and duration of narcotic needs.
Time frame: 30 days
assessment of the incidence of pneumonia (defined clinically by the treatment team), the incidence of hypoxemia, as well as readmission for pulmonary compromise.
Denver Health and Hospital Authority
Other
A Multicenter, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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