Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients

NCT02926573 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 201605121
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Acute Pain; Postoperative Pain

Keywords

oral cavity; oropharynx; hypopharynx and larynx

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled

  Once on post-op day 2 or day of discharge, whichever comes first

• 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

  Once on post-op day 2 or day of discharge, whichever comes first

• Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control

  Once on post-op day 2 or day of discharge, whichever comes first

• Mean Pain With Resting Score as Measured by VAS

  Baseline through post operative day 3

• Mean Pain With Coughing Score as Measured by VAS

  Baseline through post operative day 3

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

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

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Placebo liquid by mouth or Per Tube twice a day

Drug: Placebo

Interventions

Gabapentin DRUG

Gabapentin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing definitive mucosal head and neck resection including oral cavity, oropharynx, larynx, and hypopharynx
• At least one night of planned inpatient stay

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 29710075 DERIVED

Related Links

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

MeSH Terms

Conditions

Head and Neck Neoplasms; Acute Pain; Pain, Postoperative; Laryngeal Diseases

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

All subjects were analyzed following intention to treat principles and were included in the final analysis if greater than one night of admission was achieved before study participation ended.

Results Point of Contact

• Title: Melanie Townsend, M.D.
• Organization: Washington University School of Medicine

townsendm@wustl.edu

314-362-4470

Study Officials

• Melanie Townsend, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 6, 2016
• Study Start: June 24, 2016
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: August 8, 2018
• Results First Posted: July 11, 2018

Record last verified: 2018-07

Locations

US (1)