Effects of Perioperative Pregabalin for Post-Craniotomy Pain

• Status: Withdrawn
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Treatments: Pregabalin

Criteria

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