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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03714867
• Other study ID #: 1317015
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 22, 2019
• Est. completion date: July 7, 2020

Study information

• Verified date: July 2020
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Pain, Postoperative

Intervention

Drug:
• Pregabalin 150mg
150 mg concealed pregabalin capsule

Other:
• Placebo
Concealed placebo capsule

Locations

Country	Name	City	State
United States	Augusta University Department of Otolaryngology-Head and Neck Surgery	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. Review. — View Citation

Hwang SH, Park IJ, Cho YJ, Jeong YM, Kang JM. The efficacy of gabapentin/pregabalin in improving pain after tonsillectomy: A meta-analysis. Laryngoscope. 2016 Feb;126(2):357-66. doi: 10.1002/lary.25636. Epub 2015 Sep 25. Review. — View Citation

Kim SY, Jeong JJ, Chung WY, Kim HJ, Nam KH, Shim YH. Perioperative administration of pregabalin for pain after robot-assisted endoscopic thyroidectomy: a randomized clinical trial. Surg Endosc. 2010 Nov;24(11):2776-81. doi: 10.1007/s00464-010-1045-7. Epub 2010 Apr 8. — View Citation

Liébana-Hermoso S, Manzano-Moreno FJ, Vallecillo-Capilla MF, Olmedo-Gaya MV. Oral pregabalin for acute pain relief after cervicofacial surgery: a systematic review. Clin Oral Investig. 2018 Jan;22(1):119-129. doi: 10.1007/s00784-017-2272-2. Epub 2017 Nov 3. Review. — View Citation

Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007076. doi: 10.1002/14651858.CD007076.pub2. Review. Update in: Cochrane Database Syst Rev. 2019 Jan 23;1:CD007076. — View Citation

Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. — View Citation

Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773. — View Citation

Ringash J, Bernstein LJ, Cella D, Logemann J, Movsas B, Murphy B, Trotti A, Wells N, Yueh B, Ridge J. Outcomes toolbox for head and neck cancer research. Head Neck. 2015 Mar;37(3):425-39. doi: 10.1002/hed.23561. Epub 2015 Jan 22. Review. — View Citation

Sabatowski R, Gálvez R, Cherry DA, Jacquot F, Vincent E, Maisonobe P, Versavel M; 1008-045 Study Group. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain. 2004 May;109(1-2):26-35. — View Citation

Sanders JG, Cameron C, Dawes PJD. Gabapentin in the Management of Pain following Tonsillectomy: A Randomized Double-Blind Placebo-Controlled Trial. Otolaryngol Head Neck Surg. 2017 Nov;157(5):781-790. doi: 10.1177/0194599817719883. Epub 2017 Jul 25. — View Citation

Outcome

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