Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery

July 7, 2020 updated by: Augusta University

Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial

The purpose of this study is to evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with primary tumor resection and bilateral neck dissections. Patients will be randomly assigned to receive either pre-operative pregabalin (Lyrica) or a placebo. Patients and investigators will be blinded to which medication patients receive, and all patients will receive the same postoperative pain medication regimen with appropriate pain treatment as needed. Patients will be asked to fill out surveys prior to surgery, while in the hospital after surgery, and at each follow-up appointment for up to 24 months.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

In this study, we will utilize single-dose pre-operative administration of Lyrica (pregabalin) compared to patients who will be administered a pre-operative single-dose placebo. Pregabalin is a non-narcotic GABA analogue that has been shown to be effective for the treatment of pain associated with a variety of medical conditions. Prior studies have investigated the use of single-dose pre-operative pregabalin for analgesia in acute dental, gynecologic, endoscopic thyroidectomy, and nasal septoplasty surgical pain with encouraging results demonstrating improved overall pain scores and decreased post-operative use of narcotics. Pregabalin's use for peri-operative analgesia in head and neck cancer surgery has not been evaluated.

Patients who enroll in the study will be randomly assigned by chance to receive either a single pre-operative 150 milligram dose of pregabalin (Lyrica) or placebo in the pre-operative holding area prior to proceeding with surgery. Lyrica is a non-narcotic pain medication that has been shown to promote good control of nerve-related pain in patients. Patients who agree to enroll in the study will be asked to fill out separate questionnaires to evaluate pain and quality of life preoperatively and post-operatively.

Participants will be asked to fill out four separate questionnaires to evaluate pain and quality of life pre-operatively. Patients will be administered their respective medication, either placebo or single-dose 150 milligram concealed capsule of pregabalin, by mouth in the pre-operative holding area prior to surgery. While in the hospital after surgery, patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. Surveys will be administered and collected on a daily basis while patients are in the hospital. If patients are already utilizing other non-opioid pain medications like muscle relaxers (Flexeril, baclofen, etc.), or neuropathic pain medications (Neurontin), they will be allowed to continue these medications while inpatient provided there are no changes in dosing.

Patients will be discharged home on a seven-day course of acetaminophen with as-needed oxycodone. Outcomes surveys will then be collected at each subsequent post-operative follow up. Follow up visits will occur one week after discharge, four weeks after discharge, and then every three months until completion of the two year study period.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Department of Otolaryngology-Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English-speaking patients who are greater than eighteen years of age with a known diagnosis of head and neck cancer and are planned to undergo surgery with bilateral neck dissections will be eligible for this study.

Exclusion Criteria:

  • Patients with a history of preoperative narcotic use for conditions unrelated to their head and neck cancer will be excluded.
  • Patients younger than eighteen years of age, patients with previous severe adverse reaction to pregabalin (Lyrica), patients with a history of angioedema, and pregnant patients will be excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Treatment arm intervention consists of patients who will be administered a single enteral dose of concealed over-encapsulated Pregabalin 150mg in the pre-operative holding area. Patients will be given a post-operative regimen of 650 mg enteral acetaminophen every 6 hours and as needed oxycodone and intravenous morphine for breakthrough pain.
Drug: Pregabalin 150mg
150 mg concealed pregabalin capsule
Other Names:
  • Lyrica
Placebo Comparator: Control
Treatment arm consists of patients who will be administered a single enteral dose of concealed over-encapsulated placebo capsules in the pre-operative holding area. Patients will be given a post-operative regimen of 650 mg enteral acetaminophen every 6 hours and as needed oxycodone and intravenous morphine for breakthrough pain.
Other: Placebo
Concealed placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory
Time Frame: 2 years
Validated head and neck cancer pain scale
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defense and Veterans Pain Rating Scale
Time Frame: 2 years
Non-validated pain scale in head and neck cancer
2 years
University of Washington Quality of Life Scale Version 4 (UW-QOL-4)
Time Frame: 2 years
Validated quality of life scale in head and neck cancer
2 years
EuroQol 5D-5L
Time Frame: 2 years
Non-validated quality of life scale in head and neck cancer
2 years
Inpatient morphine equivalents
Time Frame: 1-7 days or longer depending on length of stay
Cumulative inpatient narcotic consumption
1-7 days or longer depending on length of stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Investigators

  • Principal Investigator: James K Byrd, MD, Augusta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2019

Primary Completion (Actual)

July 7, 2020

Study Completion (Actual)

July 7, 2020

Study Registration Dates

First Submitted

October 19, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1317015

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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