Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients (GABA)

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

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 Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Postoperative Pain; Acute Pain
• Intervention / Treatment: Drug: Placebo; Drug: Gabapentin

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gabapentin; Gabapentin liquid by mouth or Per Tube 300mg twice a day	Drug: Gabapentin
Placebo Comparator: Placebo; Placebo liquid by mouth or Per Tube twice a day	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily Narcotic Consumption	Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption.	Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled	-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.	Once on post-op day 2 or day of discharge, whichever comes first
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	-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.	Once on post-op day 2 or day of discharge, whichever comes first
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control	-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.	Once on post-op day 2 or day of discharge, whichever comes first
Mean Pain With Resting Score as Measured by VAS	Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.; Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain	Baseline through post operative day 3
Mean Pain With Coughing Score as Measured by VAS	Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.; Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain	Baseline through post operative day 3
Mean Pain With Swallowing Score as Measured by VAS	Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.; Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain	Baseline through post operative day 3

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Melanie Townsend, M.D., Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2016
• Primary Completion (Actual): June 21, 2017
• Study Completion (Actual): June 21, 2017

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: oropharynx; oral cavity; hypopharynx and larynx
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 201605121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No