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Effects of Perioperative Pregabalin for Post-Craniotomy Pain

WithdrawnPhase 4NCT01591980
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

Objective: To compare the incidence of chronic pain at 3 months among adults undergoing craniotomy between those received two different doses of pregabalin and those receiving placebo.

Study details

Official title
Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial
Sponsor
Unity Health Toronto
Start date
2013-08
Primary completion
2014-08
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Canada
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults, 18 to 65 years (limited to 65 years to lower the risk of over-sedation for elderly patients) * Undergoing elective craniotomy (supratentorial or infratentorial) under general anaesthesia for: biopsy or resection of a tumour, clipping of an unruptured aneurysm, or excision of an arteriovenous malformation * ASA physical status I-III Exclusion Criteria: * predicted need for prolonged post-operative ventilation (\> 12 hours) * chronic pain secondary to previous craniotomy * known adverse reaction to drugs used (gabapentin, pregabalin, hydromorphone, and/or acetaminophen) * prior use of pregabalin or gabapentin (within 2 weeks before surgery) * current history of moderate to severe headaches (NRS ≥ 4) related to intracranial pathology (tumour pain) since it may be difficult to discriminate between ongoing tumour pain and surgery-related post-operative pain * current history of migraines * pre-existing chronic pain requiring chronic opioid use (30mg morphine equivalent within 4 weeks of surgery) * currently taking any drug that could interact with pregabalin * current history of alcohol or recreational drug abuse * known or suspected addiction to narcotic substances or chronic narcotic use in the last 2 weeks * history of malignant hyperthermia (contraindicates the anaesthesia protocol of this study) * history of angioedema * Body Mass Index ≤ 18.4 or ≥ 35 * history of untreated obstructive sleep apnea * any condition that would contraindicate the use of patient-controlled analgesia (PCA) * lacks fluency in English * pre-existing renal impairment (for pregabalin elimination) * pregnancy

Canadian sites (1)

FacilityCityProvince
St. Michael's HospitalTorontoOntario

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01591980