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Completed

NCT Number: NCT02926573

Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients

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.

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Key information

Conditions

Head and Neck Cancer Acute Pain Head and Neck Neoplasms Laryngeal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: GABA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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