Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients

Postoperative Pain Clinical Trial

— GABA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926573
• Other study ID #: 201605121
• Status: Completed
• Phase: Phase 4
• Start date: June 24, 2016
• Est. completion date: June 21, 2017

Study information

• Verified date: July 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Head and Neck Cancer
• Head and Neck Neoplasms
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Gabapentin

• Placebo

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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