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Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery

NCT03682367 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-07-09

Study results available
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Summary

Patients undergoing head and neck cancer surgery often have a lot of pain after surgery, which can lead to a need for a lot of narcotic pain medication. These medications can have many side effects that can make recovery more difficult including nausea, vomiting, dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have a bowel movement, longer time before being able to start walking. These side effects can make the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that focuses on nerve pain, has been used in smaller head and neck surgeries including removal of tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn surgery have shown improved pain control with gabapentin. Potential benefits to future patients include improved pain control, less narcotic associated side effects and faster functional recovery.

Conditions

  • Cancer of Head and Neck
  • Narcotic Use

Interventions

DRUG

Gabapentin

Use of Gabapentin peri- and post-operatively.

DRUG

Placebo - Concentrate

Use of sugar-free Placebo peri- and post-operatively.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Arnaud Bewley, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-04-01
Completion
2020-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682367 on ClinicalTrials.gov