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

Primary Purpose

Head and Neck Cancer, Acute Pain, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring oral cavity, oropharynx, hypopharynx and larynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

Gabapentin liquid by mouth or Per Tube 300mg twice a day

Placebo liquid by mouth or Per Tube twice a day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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
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

Full Information

First Posted
September 26, 2016
Last Updated
July 10, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02926573
Brief Title
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients
Acronym
GABA
Official Title
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 24, 2016 (Actual)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
June 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Acute Pain, Postoperative Pain
Keywords
oral cavity, oropharynx, hypopharynx and larynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin liquid by mouth or Per Tube 300mg twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo liquid by mouth or Per Tube twice a day
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Daily Narcotic Consumption
Description
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.
Time Frame
Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.
Secondary Outcome Measure Information:
Title
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled
Description
-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.
Time Frame
Once on post-op day 2 or day of discharge, whichever comes first
Title
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
Description
-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.
Time Frame
Once on post-op day 2 or day of discharge, whichever comes first
Title
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control
Description
-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.
Time Frame
Once on post-op day 2 or day of discharge, whichever comes first
Title
Mean Pain With Resting Score as Measured by VAS
Description
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
Time Frame
Baseline through post operative day 3
Title
Mean Pain With Coughing Score as Measured by VAS
Description
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
Time Frame
Baseline through post operative day 3
Title
Mean Pain With Swallowing Score as Measured by VAS
Description
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
Time Frame
Baseline through post operative day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Townsend, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29710075
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.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients

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