Effects of Perioperative Pregabalin for Post-Craniotomy Pain (NCT01591980) | Clinical Trial Compass
WithdrawnPhase 4
Effects of Perioperative Pregabalin for Post-Craniotomy Pain
Stopped: Pfizer Canada and the SMH ORA could not come into an agreement on responsibility to be the Importer of Record for the trial.
Canada0Started 2013-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …