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

• Status: Withdrawn
• Trial end date: 2020-07-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Treatments: Pregabalin

Criteria

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.