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.
Hypothesis: Perioperative pregabalin will reduce the incidence of chronic post-operative pain, and will reduce the opioid consumption, opioid-related side effects, and hospital length of stay compared with placebo in patients undergoing elective craniotomy. Methods: 316 adults (18-65y), ASA I-III, undergoing elective craniotomy will be randomized to receive: 100mg or 150mg pregabalin or placebo once pre-operatively and 50mg or 75mg or placebo twice daily for 14 post-operative days. NRS pain scores, opioid consumption and side effects will be assessed up to 48h, and long-term pain at days 7, 14, 30, and 90. The primary analysis will involve the comparison between the 2 treatment groups together vs. placebo. A stepwise method will be used to evaluate the pairwise comparisons. Outcomes: The primary outcome will be the incidence of chronic post-craniotomy pain at 3 mos. Important secondary outcomes are: neuropathic component of pain at 3 mos., total opioid consumption in the first 24h, and incidence and severity of opioid-related side effects at days 1, 2 and 7.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Pre-operatively, one of the 2 doses of pregabalin (100 or 150 mg) or placebo will be given to patients 1 hour before the surgery. Post-operatively, patients will receive daily (split in 2 equal doses) pregabalin 100 mg, pregabalin 150 mg, or placebo for the first 14 post-operative days.
Pre-operatively, one of the 2 doses of pregabalin (100 or 150 mg) or placebo will be given to patients 1 hour before the surgery. Post-operatively, patients will receive daily (split in 2 equal doses) pregabalin 100 mg, pregabalin 150 mg, or placebo for the first 14 post-operative days.
Identical placebo capsules will be administered in the same way.
St. Michael's Hospital
Toronto, Ontario, Canada
Chronic post-craniotomy pain
The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months
Time frame: 3 months
neuropathic component of the pain at 3 months
Time frame: 3 months
incidence of long-term pain at days 7
Time frame: Day 7
incidence of long-term pain at day 14
Time frame: Day 14
incidence of long-term pain at day 30
Time frame: Day 30
total opioid consumption in the first 24h
Time frame: 24 hours
total patient-controlled analgesia (PCA)demands and delivered doses in 24h
Time frame: 24 hours
post-operative pain scores at 24h
Time frame: 24 hours
post-operative pain scores at 48h
Time frame: 48 hours
incidence and severity of opioid-related side effects at day 2
Time frame: Day 2
incidence and severity of opioid-related side effects at Day 7
Time frame: Day 7
consumption of antiemetics in the first 24h
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Time frame: 24 hours
tracheal extubation time
Time frame: within 24 hours
length of hospital stay
Time frame: 30 days