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

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ClinicalTrials.gov Identifier: NCT02926573
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : July 11, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Acute Pain Postoperative Pain Drug: Gabapentin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients: A Randomized Clinical Trial
Actual Study Start Date : June 24, 2016
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : June 21, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 daily narcotic consumption.


Secondary Outcome Measures :
  1. Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled [ Time Frame: Once on post-op day 2 or day of discharge, whichever comes first ]
    -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.

  2. 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 [ Time Frame: Once on post-op day 2 or day of discharge, whichever comes first ]
    -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.

  3. Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control [ Time Frame: Once on post-op day 2 or day of discharge, whichever comes first ]
    -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.

  4. Mean Pain With Resting Score as Measured by VAS [ Time Frame: Baseline through post operative day 3 ]
    • 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

  5. Mean Pain With Coughing Score as Measured by VAS [ Time Frame: Baseline through post operative day 3 ]
    • 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

  6. Mean Pain With Swallowing Score as Measured by VAS [ Time Frame: Baseline through post operative day 3 ]
    • 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926573


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Melanie Townsend, M.D. Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02926573     History of Changes
Other Study ID Numbers: 201605121
First Posted: October 6, 2016    Key Record Dates
Results First Posted: July 11, 2018
Last Update Posted: August 8, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Washington University School of Medicine:
oral cavity
oropharynx
hypopharynx and larynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Pain, Postoperative
Acute Pain
Neoplasms by Site
Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents