Effects of Perioperative Pregabalin for Post-Craniotomy Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01591980
• Date of registration: 09/12/2011
• Prospective Registration: Yes
• Primary sponsor: St. Michael's Hospital, Toronto
• Public title: Effects of Perioperative Pregabalin for Post-Craniotomy Pain
• Scientific title: Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial
• Date of first enrolment: August 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01591980
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Andrea Rigamonti, MD
• Affiliation: St. Michael's Hospital, Toronto

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Postoperative Pain

Headache

Intervention(s)

Drug: placebo

Drug: Pregabalin

Primary Outcome(s)

Chronic post-craniotomy pain [Time Frame: 3 months]

Secondary Outcome(s)

incidence of long-term pain at day 30 [Time Frame: Day 30]

incidence of long-term pain at days 7 [Time Frame: Day 7]

consumption of antiemetics in the first 24h [Time Frame: 24 hours]

incidence and severity of opioid-related side effects at Day 7 [Time Frame: Day 7]

length of hospital stay [Time Frame: 30 days]

post-operative pain scores at 48h [Time Frame: 48 hours]

incidence of long-term pain at day 14 [Time Frame: Day 14]

tracheal extubation time [Time Frame: within 24 hours]

total patient-controlled analgesia (PCA)demands and delivered doses in 24h [Time Frame: 24 hours]

total opioid consumption in the first 24h [Time Frame: 24 hours]

incidence and severity of opioid-related side effects at day 2 [Time Frame: Day 2]

neuropathic component of the pain at 3 months [Time Frame: 3 months]

post-operative pain scores at 24h [Time Frame: 24 hours]

Secondary ID(s)

REB-10-388

Source(s) of Monetary Support

Please refer to primary and secondary sponsors