Postoperative Pain
Conditions
Keywords
COMT, Beta-blocker, Hemicolectomy
Brief summary
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.
Interventions
DRUGIV-PCA morphine
Morphine delivered via IV-PCA pump for 48 hours after surgery with standard program: bolus 1 mg, lock out 7 minutes, no background infusion.
DRUGPropranolol PO
20 mg PO BID Day of Surgery, 30 mg PO BID Day I and Day II post-op.
DRUGPlacebo PO
Placebo tablets administered with the same schedule of Propranolol tablets
PROCEDUREQuantitative Sensory Testing (QST)
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)
GENETICCOMT-haplotypes
Assessing of High Pain Sensitivity (HPS), Average Pain Sensitivity (APS) and Low Pain Sensitivity (LPS) haplotypes for COMT by genotyping peripheral blood samples.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Elective laparoscopic hemicolectomy surgery. * Self-reported Caucasians. * ASA (American Society of Anesthesiologists) physical status of I or II. * Agrees to provide signed and dated informed consent form. * Willingness to agree with the Biobanking policy.
Exclusion criteria
* Uncontrolled medical or psychiatric conditions. * Severe mental impairment. * History of major depressive disorder, psychotic disorder or schizophrenia, and/or manic episodes within the past year. * Active alcoholism within the past 6 months. * Psychoactive recreational drug abuse within the past 6 months including MDMA, Ketamine, hallucinogens such as LSD and/or sympathomimetics such as Cocaine. * Inability to comprehend pain assessment. * Pregnancy and/or breast-feeding. * Known hypersensitivity to Beta Blockers or Opioids. * Currently taking Propranolol. * Currently taking other hypotensive treatments. * Currently taking Opioids. * Patients with asthma or reactive airway disease. * Patients with cardiac arrhythmia, coronary artery disease, congestive heart failure. * Patients with renal failure or dialysis. * Patients with liver insufficiency. * Heart rate less than 60bpm or diastolic blood pressure \<50 mmHg during the preoperative visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total morphine delivered by IV-PCA | Day II Post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Pain Threshold by digital pressure algometer | Pre-op visit, Day I Post-op, Day II Post-op, four weeks Post-op | — |
| Hyperalgesia test by von Frey hair | Pre-op visit, Day I Post-op, Day II Post-op, four weeks Post-op | — |
| Pain measured by the Numerical pain Rating Scale | 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 | — |
| Sleep quality by PSQI | Pre-op visit, 4 weeks Post-op, 3 months Post-op, 6 months Post-op | Pittsburgh Sleep Questionnaire Index (PSQI) |
| Pain quality by sfMGPQ | one evaluation during the first 8 Post-op hours, Day I Post-op, Day II Post-op | Short Form-McGill Pain Questionnaire |
| Post-operative Chronic Pain by PQRS | Pre-op visit, Day II Post-op, 4 weeks Post-op, 3 months Post-op, 6 months Post-op | Post-operative Quality of Recovery Scale (PQRS) |
| Somatization, depression and anxiety by SCL-90-R subscales | Pre-op visit | Symptom Checklist 90 Revised (SCL-90-R) subscales for somatization, depression and anxiety |
Other
| Measure | Time frame |
|---|---|
| COMT-haplotypes by blood sampling genotyping | Pre-op, Day III Post-op, 4 weeks Post-op |
Countries
Canada
Outcome results
None listed