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

NCT03714867 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 1317015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; Pain, Postoperative

Keywords

head and neck cancer; analgesia; pregabalin

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory

  Validated head and neck cancer pain scale

  2 years

Secondary Outcomes (4)

• Defense and Veterans Pain Rating Scale

  2 years

• University of Washington Quality of Life Scale Version 4 (UW-QOL-4)

  2 years

• EuroQol 5D-5L

  2 years

• Inpatient morphine equivalents

  1-7 days or longer depending on length of stay

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Placebo OTHER

Concealed placebo capsule

Control

Pregabalin 150mg DRUG

150 mg concealed pregabalin capsule

Also known as: Lyrica

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University Department of Otolaryngology-Head and Neck Surgery

Augusta, Georgia, 30912, United States

Location

Related Publications (10)

• 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.

  PMID: 26404562 BACKGROUND

• 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.

  PMID: 29049548 BACKGROUND

• 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.

  PMID: 28741425 BACKGROUND

• 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. doi: 10.1007/s40261-016-0423-x.

  PMID: 27448285 BACKGROUND

• 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.

  PMID: 19588419 BACKGROUND

• Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.

  PMID: 15315511 BACKGROUND

• Sabatowski R, Galvez 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. doi: 10.1016/j.pain.2004.01.001.

  PMID: 15082123 BACKGROUND

• Liebana-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.

  PMID: 29101547 BACKGROUND

• 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.

  PMID: 20376496 BACKGROUND

• 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.

  PMID: 24318166 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain, Postoperative; Agnosia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• James K Byrd, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients, care providers, and investigators will all be blinded to patient group identity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention is single dose. Patients will be assigned to either treatment or placebo arms. No opportunity for crossing over will be present.

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 22, 2018
• Study Start: March 22, 2019
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

US (1)