Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients

ID: NCT02926573
Status: Completed
Phase: Phase 4
Start Date: June 24, 2016
First Submitted: September 26, 2016
Last Updated: February 21, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Head and Neck Cancer, Acute Pain, Postoperative Pain
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Study Description

Brief Summary

The study will involve adult otolaryngology patients over the age of 18 years undergoing open or endoscopic/robotic tumor resection involving the mucosal surfaces of the oral cavity, oropharynx, hypopharynx and larynx at Washington University Medical Center. Eligible patients will be recruited from the otolaryngology head and neck cancer clinic during preoperative visits. Participants will be randomized to active or placebo drug and will receive study drug twice a day from Post-Op Day 0 and conclude Post-Op Day 2. Questionnaires will be collected pre-and post-operatively.

Detailed Description

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. We as providers have the duty to identify areas of needed improvement within our 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. We 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 our 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.
Condition or disease Intervention/treatment Phase

Acute Pain

Head and Neck Cancer

Postoperative Pain

Drug: Gabapentin
Other Names
Drug: Placebo
Other Names
Phase 4

Tracking Information

First Submitted DateSeptember 26, 2016
Last Update Posted DateFebruary 21, 2018
Actual Start DateJune 24, 2016
Actual Completion DateJune 21, 2017
Actual Primary Completion DateJune 21, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Average Change in daily narcotic consumption [Time Frame: Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.]

    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 average daily narcotic consumption.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Post-treatment satisfaction score [Time Frame: Once on post-op day 2 or day of discharge, whichever comes first]

    -A point system is created with the sum of the numeric values assigned to questions 1-3 on a scale of 0 to 10, with a score of 0-3 indicates overall dissatisfaction, 4 indicates neutrality, and 5-10 suggests overall satisfaction. This will be analyzed as an ordinal variable

  • Pain score [Time Frame: Change from baseline pain score at post operative day 3]

    Visual Analogue Pain Score (VAS) - 10 point scale

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitlePerioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients
Official TitlePerioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients: A Randomized Clinical Trial
Brief Summary

The study will involve adult otolaryngology patients over the age of 18 years undergoing open or endoscopic/robotic tumor resection involving the mucosal surfaces of the oral cavity, oropharynx, hypopharynx and larynx at Washington University Medical Center. Eligible patients will be recruited from the otolaryngology head and neck cancer clinic during preoperative visits. Participants will be randomized to active or placebo drug and will receive study drug twice a day from Post-Op Day 0 and conclude Post-Op Day 2. Questionnaires will be collected pre-and post-operatively.

Detailed Description

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. We as providers have the duty to identify areas of needed improvement within our 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. We 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 our 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 TypeInterventional
Study PhasePhase 4
Estimated Enrollment
110
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Acute Pain
Head and Neck Cancer
Postoperative Pain
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Gabapentin

Other Names
Drug: Placebo

Other Names
Study Groups/Cohorts
Study Drug
Gabapentin liquid by mouth or Per Tube 300mg twice a day

Placebo
Placebo liquid by mouth or Per Tube twice a day

Study Arms
Placebo Comparator Placebo
Placebo liquid by mouth or Per Tube twice a day
Drug : Placebo

Active Comparator Study Drug
Gabapentin liquid by mouth or Per Tube 300mg twice a day
Drug : Gabapentin

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

Recruitment Information

Recruitment Status:Completed
Enrollment110
Completion DateJune 21, 2017
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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02926573
Other Study ID Numbers
201605121
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Melanie Townsend, M.D.
Washington University School of Medicine