Genetic Predictors of Analgesic Efficacy of Propranolol for Treating Postoperative Pain
Phase 2
Terminated
- Conditions
- Postoperative Pain
- Interventions
- Drug: Placebo POProcedure: Quantitative Sensory Testing (QST)Other: Psychometric assessmentGenetic: COMT-haplotypes
- Registration Number
- NCT02511483
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV-PCA morphine + Propranolol PO Propranolol PO The morning of the surgery a dose of Propranolol 20 mg PO will be administered. After surgery pain control will be performed with IV-PCA morphine; in addition a second dose of Propranolol 20 mg PO will be administered . During the first and second postoperative day Propranolol 30 mg PO (BID) will be administered. Parallel assessment of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Placebo PO IV-PCA morphine Pain control after surgery will be performed through IV-PCA morphine. Placebo will be administered with the same schedule of Propranolol in the experimental arm. Parallel evaluation of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Placebo PO Placebo PO Pain control after surgery will be performed through IV-PCA morphine. Placebo will be administered with the same schedule of Propranolol in the experimental arm. Parallel evaluation of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Placebo PO Quantitative Sensory Testing (QST) Pain control after surgery will be performed through IV-PCA morphine. Placebo will be administered with the same schedule of Propranolol in the experimental arm. Parallel evaluation of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Placebo PO Psychometric assessment Pain control after surgery will be performed through IV-PCA morphine. Placebo will be administered with the same schedule of Propranolol in the experimental arm. Parallel evaluation of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Placebo PO COMT-haplotypes Pain control after surgery will be performed through IV-PCA morphine. Placebo will be administered with the same schedule of Propranolol in the experimental arm. Parallel evaluation of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Propranolol PO IV-PCA morphine The morning of the surgery a dose of Propranolol 20 mg PO will be administered. After surgery pain control will be performed with IV-PCA morphine; in addition a second dose of Propranolol 20 mg PO will be administered . During the first and second postoperative day Propranolol 30 mg PO (BID) will be administered. Parallel assessment of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Propranolol PO Quantitative Sensory Testing (QST) The morning of the surgery a dose of Propranolol 20 mg PO will be administered. After surgery pain control will be performed with IV-PCA morphine; in addition a second dose of Propranolol 20 mg PO will be administered . During the first and second postoperative day Propranolol 30 mg PO (BID) will be administered. Parallel assessment of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Propranolol PO Psychometric assessment The morning of the surgery a dose of Propranolol 20 mg PO will be administered. After surgery pain control will be performed with IV-PCA morphine; in addition a second dose of Propranolol 20 mg PO will be administered . During the first and second postoperative day Propranolol 30 mg PO (BID) will be administered. Parallel assessment of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial. IV-PCA morphine + Propranolol PO COMT-haplotypes The morning of the surgery a dose of Propranolol 20 mg PO will be administered. After surgery pain control will be performed with IV-PCA morphine; in addition a second dose of Propranolol 20 mg PO will be administered . During the first and second postoperative day Propranolol 30 mg PO (BID) will be administered. Parallel assessment of Quantitative Sensory Testing (QST), Psychometric assessment and COMT-haplotypes will be included along the trial.
- Primary Outcome Measures
Name Time Method Total morphine delivered by IV-PCA Day II Post-op
- Secondary Outcome Measures
Name Time Method 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 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
Sleep quality by PSQI Pre-op visit, 4 weeks Post-op, 3 months Post-op, 6 months Post-op Pittsburgh Sleep Questionnaire Index (PSQI)
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)
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
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
Trial Locations
- Locations (2)
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada