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 range
18 Years – 65 Years
Sex
ALL
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.