Postoperative PainPhase 2PRO_GENE_POPNCT02511483
Genetic Predictors of Analgesic Efficacy of Propranolol for Treating Postoperative Pain
A Phase 2 study testing Propranolol PO, IV-PCA morphine and Quantitative Sensory Testing (QST) in people with Postoperative Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Propranolol PO, IV-PCA morphine and Quantitative Sensory Testing (QST)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- 18 May 2015to 12 Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
About this study
Official title: Contribution of COMT Haplotypes in Propranolol Analgesic Efficacy for Treating Post-surgical Pain After Laparoscopic Hemicolectomy
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.
- Conditions
- Postoperative Pain
- Being tested
- Propranolol PO, IV-PCA morphine, Placebo PO, Quantitative Sensory Testing (QST), Psychometric assessment
- Keywords
- COMT, Beta-blocker, Hemicolectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol PODrug
Also called CAS No 525-66-6, DINs: 00740675, 00496480
20 mg PO BID Day of Surgery, 30 mg PO BID Day I and Day II post-op.
IV-PCA morphineDrug
Also called Patient controlled Analgesia with intravenous 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.
Placebo PODrug
Also called tablet containing microcrystalline cellulose
Placebo tablets administered with the same schedule of Propranolol tablets
Quantitative Sensory Testing (QST)Procedure or surgery
Also called Pressure Pain Threshold and Hyperalgesia test
Assessment of PPT (Pressure Pain Threshold) by pressure algometer and assessment of the post-op area of hyperalgesia by von Frey hair no. 16.
Psychometric assessmentOther
Also called PSQI, sfMGPQ, SCL-90-R, PQRS
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)
COMT-haplotypesGenetic
Also called HPS, APS, LPS
Assessing of High Pain Sensitivity (HPS), Average Pain Sensitivity (APS) and Low Pain Sensitivity (LPS) haplotypes for COMT by genotyping peripheral blood samples.
| Study group | Role | What they receive |
|---|---|---|
| IV-PCA morphine + Placebo PO | Placebo comparator | 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. Receives: Drug: IV-PCA morphine; Drug: Placebo PO; Procedure: Quantitative Sensory Testing (QST); Other: Psychometric assessment; Genetic: COMT-haplotypes |
| IV-PCA morphine + Propranolol PO | Experimental | 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. Receives: Drug: Propranolol PO; Drug: IV-PCA morphine; Procedure: Quantitative Sensory Testing (QST); Other: Psychometric assessment; Genetic: COMT-haplotypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine delivered by IV-PCA
Measured: Day II Post-op
Secondary outcomes (7)
Pressure Pain Threshold by digital pressure algometer
Measured: Pre-op visit, Day I Post-op, Day II Post-op, four weeks Post-op
Hyperalgesia test by von Frey hair
Measured: Pre-op visit, Day I Post-op, Day II Post-op, four weeks Post-op
Pain measured by the Numerical pain Rating Scale
Measured: 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
Measured: Pre-op visit
Sleep quality by PSQI
Pittsburgh Sleep Questionnaire Index (PSQI)
Measured: Pre-op visit, 4 weeks Post-op, 3 months Post-op, 6 months Post-op
Pain quality by sfMGPQ
Short Form-McGill Pain Questionnaire
Measured: 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)
Measured: Pre-op visit, Day II Post-op, 4 weeks Post-op, 3 months Post-op, 6 months Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study start18 May 2015
- Primary completion12 Nov 2016
- Study completion12 Nov 2016
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Luda Diatchenko, Professor, Principal investigator, Anesthesia Department McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511483
- Sponsor's protocol ID
- 15-169-MUHC
- Acronym
- PRO_GENE_POP
- Status last verified
- Sep 2021
- First submitted
- 23 Jul 2015
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25084070Tchivileva 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.
PubMed 20216107Zaugg 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. doi: 10.1097/00000542-199912000-00020.
PubMed 10598610Schweinhardt 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.
PubMed 23070986Pranevicius 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. No abstract available.
PubMed 19224829Chia 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. doi: 10.1093/bja/aeh268. Epub 2004 Sep 17.
PubMed 15377583Chen 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.
PubMed 22842397Zhang 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.
PubMed 25532715Diatchenko 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. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10.
PubMed 15537663
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of COMT Haplotypes in Propranolol Analgesic Efficacy for Treating Post-surgical Pain After Laparoscopic Hemicolectomy
- ClinicalTrials.gov ID
- NCT02511483
- Acronym / sponsor ID
- PRO_GENE_POP / 15-169-MUHC
- Conditions
- Postoperative Pain
- Keywords
- COMT, Beta-blocker, Hemicolectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 18 May 2015 (actual)
- Primary completion
- 12 Nov 2016 (actual)
- Study completion
- 12 Nov 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV-PCA morphine + Placebo PO | Placebo comparator | Drug: IV-PCA morphine, Drug: Placebo PO, Procedure: Quantitative Sensory Testing (QST), Other: Psychometric assessment, Genetic: COMT-haplotypesPain 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 | Experimental | Drug: Propranolol PO, Drug: IV-PCA morphine, Procedure: Quantitative Sensory Testing (QST), Other: Psychometric assessment, Genetic: COMT-haplotypesThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol POAlso: CAS No 525-66-6, DINs: 00740675, 0049648020 mg PO BID Day of Surgery, 30 mg PO BID Day I and Day II post-op. | Drug | IV-PCA morphine + Propranolol PO |
| IV-PCA morphineAlso: Patient controlled Analgesia with intravenous morphineMorphine delivered via IV-PCA pump for 48 hours after surgery with standard program: bolus 1 mg, lock out 7 minutes, no background infusion. | Drug | IV-PCA morphine + Placebo PO, IV-PCA morphine + Propranolol PO |
| Placebo POAlso: tablet containing microcrystalline cellulosePlacebo tablets administered with the same schedule of Propranolol tablets | Drug | IV-PCA morphine + Placebo PO |
| Quantitative Sensory Testing (QST)Also: Pressure Pain Threshold and Hyperalgesia testAssessment of PPT (Pressure Pain Threshold) by pressure algometer and assessment of the post-op area of hyperalgesia by von Frey hair no. 16. | Procedure or surgery | IV-PCA morphine + Placebo PO, IV-PCA morphine + Propranolol PO |
| Psychometric assessmentAlso: PSQI, sfMGPQ, SCL-90-R, PQRSQuestionnaires 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) | Other | IV-PCA morphine + Placebo PO, IV-PCA morphine + Propranolol PO |
| COMT-haplotypesAlso: HPS, APS, LPSAssessing of High Pain Sensitivity (HPS), Average Pain Sensitivity (APS) and Low Pain Sensitivity (LPS) haplotypes for COMT by genotyping peripheral blood samples. | Genetic | IV-PCA morphine + Placebo PO, IV-PCA morphine + Propranolol PO |
Primary outcome
Total morphine delivered by IV-PCA
Time frame: Day II Post-op
7 secondary outcomes
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
Time frame: Pre-op visit
Sleep quality by PSQI
Time frame: Pre-op visit, 4 weeks Post-op, 3 months Post-op, 6 months Post-op
Pain quality by sfMGPQ
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
Time frame: Pre-op visit, Day II Post-op, 4 weeks Post-op, 3 months Post-op, 6 months Post-op
Results and safety
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 25084070Orrey 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.
- Background: PubMed 20216107Tchivileva 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.
- Background: PubMed 10598610Zaugg 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. doi: 10.1097/00000542-199912000-00020.
- Background: PubMed 23070986Schweinhardt 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.
- Background: PubMed 19224829Pranevicius 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. No abstract available.
- Background: PubMed 15377583Chia 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. doi: 10.1093/bja/aeh268. Epub 2004 Sep 17.
- Background: PubMed 22842397Chen 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.
- Background: PubMed 25532715Zhang 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.
- Background: PubMed 15537663Diatchenko 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. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luda Diatchenko, Professor principal investigator
Anesthesia Department McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol PO, IV-PCA morphine and Quantitative Sensory Testing (QST) in people with Postoperative Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine delivered by IV-PCA (time frame: Day II Post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511483, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.