Clinical trial · Interventional
Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to recruit patients
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Pregabalin 150mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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.
- interventionNames
- Drug: Pregabalin 150mg
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- 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.
- interventionNames
- Other: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDHwang 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
- BACKGROUNDOltman 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
- BACKGROUNDSanders 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
- BACKGROUNDOgawa 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
- BACKGROUNDMoore 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
- BACKGROUNDBen-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
- BACKGROUNDSabatowski 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.