CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 123 enrolled
Drug / intervention
Gabapentin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02926573
NCT02926573Phase 4Completed

Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients: A Randomized Clinical Trial

Washington University School of Medicine·interventional·Posted Oct 6, 2016·Updated Aug 8, 2018

In Brief

A Phase 4 clinical trial evaluating Gabapentin and Placebo for Head and Neck Cancer and 2 related conditions. Completed, enrolled 123 participants across 1 site.

Detailed Summary

Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect provider and hospital quality of care. Furthermore, at the core of a healthcare team and healthcare system is the desire to provide patients with the best possible care in order to achieve the best possible outcomes. Providers have the duty to identify areas of needed improvement within the domains of treatment. An area of need that is ubiquitous within medicine is pain control; in this case acute postoperative pain control is the targeted condition. Studies have already shown that better control of acute postoperative pain leads to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient satisfaction and a reduced likelihood of developing chronic pain. Research within the field of pain management has definitively revealed that a combination of different medication regimens can control acute postoperative pain better than narcotics alone. In particular, the medication gabapentin has been shown to improve acute postop pain in many kinds of surgical settings, and it is a safe medication with arguably fewer side effects than narcotics. The investigators know that certain groups of post surgical otolaryngology patients can be at risk for high levels of postoperative pain. Given all of this information, physicians have a responsibility to utilize medications such as gabapentin to do a better job of controlling patient's pain. This investigation is a quality improvement project designed to elucidate the benefits of gabapentin in pain management in patients undergoing surgery of the head and neck mucosal surfaces. It will provide much needed data in an understudied population and ultimately will improve the practice of pain management, patient satisfaction and quality of care delivered in the Barnes otolaryngology department.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 6, 2016
Enrollment StartJun 24, 2016
Primary CompletionJun 21, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.7 years ago

Interventions

Gabapentindrug

Placebodrug