Clinical trial NCT02926573: Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients
Official title: Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Head and Neck Cancer
Acute Pain
Postoperative Pain
Keywords: oral cavity
oropharynx
hypopharynx and larynx
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing definitive mucosal head and neck resection including oral cavity, oropharynx, larynx, and hypopharynx
* At least one night of planned inpatient stay

Exclusion Criteria:

* Incapable of giving informed consent
* Age less than 18
* Glomerular Filtration Rate (GFR) less than 30
* Allergy to gabapentin
* Baseline gabapentin or lyrica use
* Chronic opioid use for over six months

Primary outcomes:
measure: Change in Daily Narcotic Consumption
timeFrame: Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.
Secondary outcomes:
measure: Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled
timeFrame: Once on post-op day 2 or day of discharge, whichever comes first
measure: Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain
timeFrame: Once on post-op day 2 or day of discharge, whichever comes first
measure: Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control
timeFrame: Once on post-op day 2 or day of discharge, whichever comes first
measure: Mean Pain With Resting Score as Measured by VAS
timeFrame: Baseline through post operative day 3
measure: Mean Pain With Coughing Score as Measured by VAS
timeFrame: Baseline through post operative day 3
measure: Mean Pain With Swallowing Score as Measured by VAS
timeFrame: Baseline through post operative day 3
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Melanie Townsend, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Townsend M, Liou T, Kallogjeri D, Schoer M, Scott-Wittenborn N, Lindburg M, Bottros M, Jackson RS, Nussenbaum B, Piccirillo JF. Effect of Perioperative Gabapentin Use on Postsurgical Pain in Patients Undergoing Head and Neck Mucosal Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):959-966. doi: 10.1001/jamaoto.2018.0282.