Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01591980 |
Date of registration:
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09/12/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effects of Perioperative Pregabalin for Post-Craniotomy Pain
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Scientific title:
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Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial |
Date of first enrolment:
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August 2013 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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http://clinicaltrials.gov/show/NCT01591980 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Andrea Rigamonti, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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St. Michael's Hospital, Toronto |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Chronic Postoperative Pain
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Headache
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Intervention(s)
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Drug: placebo
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Drug: Pregabalin
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Primary Outcome(s)
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Chronic post-craniotomy pain
[Time Frame: 3 months]
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Secondary Outcome(s)
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consumption of antiemetics in the first 24h
[Time Frame: 24 hours]
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incidence and severity of opioid-related side effects at Day 7
[Time Frame: Day 7]
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incidence of long-term pain at day 14
[Time Frame: Day 14]
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tracheal extubation time
[Time Frame: within 24 hours]
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incidence and severity of opioid-related side effects at day 2
[Time Frame: Day 2]
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neuropathic component of the pain at 3 months
[Time Frame: 3 months]
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total patient-controlled analgesia (PCA)demands and delivered doses in 24h
[Time Frame: 24 hours]
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post-operative pain scores at 24h
[Time Frame: 24 hours]
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incidence of long-term pain at day 30
[Time Frame: Day 30]
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incidence of long-term pain at days 7
[Time Frame: Day 7]
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length of hospital stay
[Time Frame: 30 days]
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post-operative pain scores at 48h
[Time Frame: 48 hours]
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total opioid consumption in the first 24h
[Time Frame: 24 hours]
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Secondary ID(s)
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REB-10-388
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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