Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery
Withdrawn before enrolling · Phase 4 · Has a placebo group
Conditions studied: Head and Neck Cancer, Pain, Postoperative
In brief
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.
Key facts
- Study ID
- NCT03714867
- Run by
- Augusta University
- People needed
- 0
- Starts
- 2019-03-22
- Expected to finish
- 2020-07-07
- Last updated by the study team
- 2020-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Augusta University Department of Otolaryngology-Head and Neck Surgery — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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