This study is a randomized, double-blind, placebo controlled clinical trial. The main purpose of this study is to determine if postsurgical pain ratings are improved with treatment with oral Propranolol, and if the effectiveness of treatment can be modified by the presence or absence of SNPs (Single Nucleotide Polymorphism) associated with Cathecol-O-MethylTransferase (COMT) and mu-opioid receptor (MOR1) activity. The treatment period will last for three days and the observation period will last for six months. Effectiveness of treatment will be assessed by means of morphine consumption through quantitative evaluation of IV-PCA (Patient Controlled Analgesia) morphine as primary outcome measure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
20 mg PO BID Day of Surgery, 30 mg PO BID Day I and Day II post-op.
Morphine delivered via IV-PCA pump for 48 hours after surgery with standard program: bolus 1 mg, lock out 7 minutes, no background infusion.
Placebo tablets administered with the same schedule of Propranolol tablets
Assessment of PPT (Pressure Pain Threshold) by pressure algometer and assessment of the post-op area of hyperalgesia by von Frey hair no. 16.
Questionnaires assessing for sleep quality (PSQI: Pittsburgh Sleep Quality Index), pain quality (sfMGPQ-Short Form-McGill Pain Questionnaire), somatization-depression-anxiety (SCL-90-R: Symptom Checklist 90 Revised), evolution of post-operative chronic pain (PQRS: Post-operative Quality of Recovery Scale)
Assessing of High Pain Sensitivity (HPS), Average Pain Sensitivity (APS) and Low Pain Sensitivity (LPS) haplotypes for COMT by genotyping peripheral blood samples.
Montreal General Hospital
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Total morphine delivered by IV-PCA
Time frame: Day II Post-op
Pressure Pain Threshold by digital pressure algometer
Time frame: Pre-op visit, Day I Post-op, Day II Post-op, four weeks Post-op
Hyperalgesia test by von Frey hair
Time frame: Pre-op visit, Day I Post-op, Day II Post-op, four weeks Post-op
Pain measured by the Numerical pain Rating Scale
Time frame: Pre-op visit, one evaluation during the first 8 Post-op hours, Day I Post-op, Day II Post-op, 4 weeks Post-op, 3 month Post-op, 6 months Post-op
Somatization, depression and anxiety by SCL-90-R subscales
Symptom Checklist 90 Revised (SCL-90-R) subscales for somatization, depression and anxiety
Time frame: Pre-op visit
Sleep quality by PSQI
Pittsburgh Sleep Questionnaire Index (PSQI)
Time frame: Pre-op visit, 4 weeks Post-op, 3 months Post-op, 6 months Post-op
Pain quality by sfMGPQ
Short Form-McGill Pain Questionnaire
Time frame: one evaluation during the first 8 Post-op hours, Day I Post-op, Day II Post-op
Post-operative Chronic Pain by PQRS
Post-operative Quality of Recovery Scale (PQRS)
Time frame: Pre-op visit, Day II Post-op, 4 weeks Post-op, 3 months Post-op, 6 months Post-op
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