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Genetic Predictors of Analgesic Efficacy of Propranolol for Treating Postoperative Pain

Information source: McGill University Health Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Propranolol PO (Drug); IV-PCA morphine (Drug); Placebo PO (Drug); Quantitative Sensory Testing (QST) (Procedure); Psychometric assessment (Other); COMT-haplotypes (Genetic)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: McGill University Health Center

Official(s) and/or principal investigator(s):
Luda Diatchenko, Professor, Principal Investigator, Affiliation: Anesthesia Department McGill University

Overall contact:
Franco Carli, Professor, Phone: 514 934 1934, Ext: 43261, Email: franco.carli@mcgill.ca


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.

Clinical Details

Official title: Contribution of COMT Haplotypes in Propranolol Analgesic Efficacy for Treating Post-surgical Pain After Laparoscopic Hemicolectomy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Total morphine delivered by IV-PCA

Secondary outcome:

Pressure Pain Threshold by digital pressure algometer

Hyperalgesia test by von Frey hair

Pain measured by the Numerical pain Rating Scale

Somatization, depression and anxiety by SCL-90-R subscales

Sleep quality by PSQI

Pain quality by sfMGPQ

Post-operative Chronic Pain by PQRS


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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.

Locations and Contacts

Franco Carli, Professor, Phone: 514 934 1934, Ext: 43261, Email: franco.carli@mcgill.ca

Additional Information

Human Pain Genetic Lab

Related publications:

Orrey DC, Halawa OI, Bortsov AV, Shupp JW, Jones SW, Haith LR, Hoskins JM, Jordan MH, Bangdiwala SI, Roane BR, Platts-Mills TF, Holmes JH, Hwang J, Cairns BA, McLean SA. Results of a pilot multicenter genotype-based randomized placebo-controlled trial of propranolol to reduce pain after major thermal burn injury. Clin J Pain. 2015 Jan;31(1):21-9. doi: 10.1097/AJP.0000000000000086.

Tchivileva IE, Lim PF, Smith SB, Slade GD, Diatchenko L, McLean SA, Maixner W. Effect of catechol-O-methyltransferase polymorphism on response to propranolol therapy in chronic musculoskeletal pain: a randomized, double-blind, placebo-controlled, crossover pilot study. Pharmacogenet Genomics. 2010 Apr;20(4):239-48. doi: 10.1097/FPC.0b013e328337f9ab.

Zaugg M, Tagliente T, Lucchinetti E, Jacobs E, Krol M, Bodian C, Reich DL, Silverstein JH. Beneficial effects from beta-adrenergic blockade in elderly patients undergoing noncardiac surgery. Anesthesiology. 1999 Dec;91(6):1674-86.

Schweinhardt P, Abulhasan YB, Koeva V, Balderi T, Kim DJ, Alhujairi M, Carli F. Effects of intravenous propranolol on heat pain sensitivity in healthy men. Eur J Pain. 2013 May;17(5):704-13. doi: 10.1002/j.1532-2149.2012.00231.x. Epub 2012 Oct 16.

Pranevicius M, Pranevicius O. Non-opioid anesthesia with esmolol avoids opioid-induced hyperalgesia and reduces fentanyl requirement after laparoscopy. Anesth Analg. 2009 Mar;108(3):1048. doi: 10.1213/ane.0b013e3181938f3f.

Chia YY, Chan MH, Ko NH, Liu K. Role of beta-blockade in anaesthesia and postoperative pain management after hysterectomy. Br J Anaesth. 2004 Dec;93(6):799-805. Epub 2004 Sep 17.

Chen YW, Chu CC, Chen YC, Hung CH, Wang JJ. Propranolol elicits cutaneous analgesia against skin nociceptive stimuli in rats. Neurosci Lett. 2012 Aug 30;524(2):129-32. doi: 10.1016/j.neulet.2012.07.036. Epub 2012 Jul 26.

Zhang F, Tong J, Hu J, Zhang H, Ouyang W, Huang D, Tang Q, Liao Q. COMT gene haplotypes are closely associated with postoperative fentanyl dose in patients. Anesth Analg. 2015 Apr;120(4):933-40. doi: 10.1213/ANE.0000000000000563.

Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W. Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. Epub 2004 Nov 10.

Starting date: September 2015
Last updated: July 27, 2015

Page last updated: August 23, 2015

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