Chronic PainNCT02697812
Does the Speed of Sternal Retraction Affect Postoperative Pain Outcomes
A study testing slow sternal retraction in people with Chronic Pain, run by Dr. Tarit Saha at 1 site in Canada.
Trial summary
In North America, almost ½ million people undergo coronary artery bypass graft surgery annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus standard-of-care (sternal opening over 30… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- slow sternal retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Dec 2020
- Phase
- Interventional
- 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 coronary artery bypass graft surgery
- understand written informed consent
- ASA I,II or III
Who cannot join
- revision cardiac surgery
- current alcohol/substance abuse
- pre-existing chronic pain requiring chronic analgesic use
- rest pain in proposed surgical area preoperatively
- chronic steroid use
- inability to perform postoperative assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Speed of Sternal Retraction During Coronary Artery Bypass Graft Surgery Affect Postoperative Pain Outcomes: A Randomized Controlled Trial
In North America, almost ½ million people undergo coronary artery bypass graft surgery annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus standard-of-care (sternal opening over 30 seconds) and examine the incidence and severity of chronic post-sternotomy pain (CPSP) and quality-of life 3, 6 and 12 months post-operatively. The severity of acute post-operative pain will also be measured. Increased retraction time reduces forces required, which should translate to reduced nerve/tissue damage. If effective, this simple change in practice could be readily implemented with a major impact for patients and the health care system overall.
Read the detailed description
The overall objective of the current investigation is to determine whether increasing the time to sternal retraction to 15 minutes (from the standard ~30 sec), will result in reduced acute and chronic post-sternotomy pain and an improved quality of life. The hypothesis here is that increased time to sternal retraction will result in: reduced required force, less physical trauma, less inflammation, and less nerve damage. Specifically, the hypothesis is that slow steady sternal retraction (occurring over 15 minutes) will 1) reduce the incidence of CPSP by 40% 2) reduce the severity of acute postoperative pain by at least 20-30% and 3) significantly improve quality of life 6 months postoperatively.
The current investigation will be a prospective blinded, randomized, controlled trial. Following institutional ethics approval and signed consent, eligible patients scheduled for elective coronary artery bypass graft surgery will be randomly assigned (stratified by gender and surgeon to ensure equality between groups) either to the Standard group (in which sternal retraction occurs over ~30s) or the Slow group in which sternal retraction occurs over 15 minutes. Patients and research personnel performing the postoperative assessments will remain blinded to group assignment until conclusion of the investigation. All other intra-operative variables will be performed as per standard practice by the cardiac surgeons at Kingston General Hospital. The extent of sternal retraction will be to the surgeon's discretion to enable appropriate exposure of the heart to allow safe conduct of the operation but it will be recorded in all cases.
The primary outcome measure will be the incidence of chronic post-sternotomy chest pain 6 months following CABG with median sternotomy. However, we will also measure the incidence of CPSP at 3 and 12 months to determine the trajectory. Secondary outcomes will include: Pain intensity (numeric rating scale-NRS) of chest pain (which differs from preoperative) at rest and while coughing daily while in hospital until discharge and at 1 week postoperatively. Analgesic consumption (morphine equivalents) daily while in hospital until discharge, 1 week post-operatively and then at 3, 6, and 12 months postoperatively. Intra-operative data will include time from initiation to full retraction, latency from full retraction to sternal closure, width of sternal opening at full retraction. Pain quality, quality of life, and pain interference with daily function at 3, 6 and 12 months post-operatively. All assessments following discharge from the hospital will be via telephone calls from a research nurse blinded to randomization assignment. In-hospital assessments will also be done by a research nurse blinded to group assignment.
- Conditions
- Chronic Pain
- Being tested
- slow sternal retraction
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slow sternal retractionProcedure or surgery
Also called slow retraction
the sternal retraction (which always need to be performed for coronary artery bypass graft surgery) will be achieved over 15 min instead of the usual 30 sec
| Study group | Role | What they receive |
|---|---|---|
| slow sternal retraction | Experimental | sternal retraction (which is required for exposure of the heart during coronary artery bypass graft surgery) will be performed gradually over 15 minutes Receives: Procedure: slow sternal retraction |
| standard sternal retraction | No intervention | sternal retraction will be performed as per standard practice (sternum opened rapidly over 30 sec.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic post-sternotomy pain
incidence of chronic post-sternotomy pain 6 months following coronary artery bypass graft surgery
Measured: 6 months postoperatively
Secondary outcomes (7)
Incidence of chronic post-sternotomy pain
incidence of chronic pain
Measured: 3 and 12 months postoperatively
severity of chronic postoperative pain
pain on NRS scale
Measured: 3 months. 6 months, 1 year
severity of acute postoperative pain at rest and with coughing
pain on NRS scale
Measured: daily while an inpatient up to 1 week postoperatively
analgesic consumption
Measured: daily while an inpatient up to 1 week postoperatively, 1 week postoperatively, 3, 6 and 12 months postoperatively
quality of life with the Modified Brief Pain Inventory (BPI)
Measured: 3, 6, 12 months postoperatively
pain quality with the Douleur Neuropathique Questionnaire (DN4)
Measured: 3, 6 and 12 months postoperatively
pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)
Measured: 3, 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Tarit Saha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Tarit Saha, Queen's University
- Investigators
- Tarit Saha, MD, FRCPC, Principal investigator, Queen's University/Kingston General HospitalDimitri Petsikas, MD, FRCSC, Principal investigator, Queen's University/ Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697812
- Sponsor's protocol ID
- ANAE-233-13
- Status last verified
- May 2023
- First submitted
- 3 Dec 2015
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Phelan R, Petsikas D, Shelley J, Hopman WM, DuMerton D, Parry M, Payne D, Allard R, Cummings M, Parlow JL, Tanzola R, Wang LTS, Stewart C, Saha TK. Retraction speed and chronic poststernotomy pain: A randomized controlled trial. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1560-1567.e1. doi: 10.1016/j.jtcvs.2023.11.037. Epub 2023 Nov 30.
PubMed 38042399
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Speed of Sternal Retraction During Coronary Artery Bypass Graft Surgery Affect Postoperative Pain Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02697812
- Acronym / sponsor ID
- ANAE-233-13
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Dr. Tarit SahaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 3 Mar 2016 (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.
In North America, almost ½ million people undergo coronary artery bypass graft surgery annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus standard-of-care (sternal opening over 30 seconds) and examine the incidence and severity of chronic post-sternotomy pain (CPSP) and quality-of life 3, 6 and 12 months post-operatively. The severity of acute post-operative pain will also be measured. Increased retraction time reduces forces required, which should translate to reduced nerve/tissue damage. If effective, this simple change in practice could be readily implemented with a major impact for patients and the health care system overall.
Detailed description
The overall objective of the current investigation is to determine whether increasing the time to sternal retraction to 15 minutes (from the standard ~30 sec), will result in reduced acute and chronic post-sternotomy pain and an improved quality of life. The hypothesis here is that increased time to sternal retraction will result in: reduced required force, less physical trauma, less inflammation, and less nerve damage. Specifically, the hypothesis is that slow steady sternal retraction (occurring over 15 minutes) will 1) reduce the incidence of CPSP by 40% 2) reduce the severity of acute postoperative pain by at least 20-30% and 3) significantly improve quality of life 6 months postoperatively.
The current investigation will be a prospective blinded, randomized, controlled trial. Following institutional ethics approval and signed consent, eligible patients scheduled for elective coronary artery bypass graft surgery will be randomly assigned (stratified by gender and surgeon to ensure equality between groups) either to the Standard group (in which sternal retraction occurs over ~30s) or the Slow group in which sternal retraction occurs over 15 minutes. Patients and research personnel performing the postoperative assessments will remain blinded to group assignment until conclusion of the investigation. All other intra-operative variables will be performed as per standard practice by the cardiac surgeons at Kingston General Hospital. The extent of sternal retraction will be to the surgeon's discretion to enable appropriate exposure of the heart to allow safe conduct of the operation but it will be recorded in all cases.
The primary outcome measure will be the incidence of chronic post-sternotomy chest pain 6 months following CABG with median sternotomy. However, we will also measure the incidence of CPSP at 3 and 12 months to determine the trajectory. Secondary outcomes will include: Pain intensity (numeric rating scale-NRS) of chest pain (which differs from preoperative) at rest and while coughing daily while in hospital until discharge and at 1 week postoperatively. Analgesic consumption (morphine equivalents) daily while in hospital until discharge, 1 week post-operatively and then at 3, 6, and 12 months postoperatively. Intra-operative data will include time from initiation to full retraction, latency from full retraction to sternal closure, width of sternal opening at full retraction. Pain quality, quality of life, and pain interference with daily function at 3, 6 and 12 months post-operatively. All assessments following discharge from the hospital will be via telephone calls from a research nurse blinded to randomization assignment. In-hospital assessments will also be done by a research nurse blinded to group assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slow sternal retraction | Experimental | Procedure: slow sternal retractionsternal retraction (which is required for exposure of the heart during coronary artery bypass graft surgery) will be performed gradually over 15 minutes |
| standard sternal retraction | No intervention | –sternal retraction will be performed as per standard practice (sternum opened rapidly over 30 sec.) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective coronary artery bypass graft surgery
- understand written informed consent
- ASA I,II or III
Key exclusion criteria (6 listed)
- revision cardiac surgery
- current alcohol/substance abuse
- pre-existing chronic pain requiring chronic analgesic use
- rest pain in proposed surgical area preoperatively
- chronic steroid use
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 |
|---|---|---|
| slow sternal retractionAlso: slow retractionthe sternal retraction (which always need to be performed for coronary artery bypass graft surgery) will be achieved over 15 min instead of the usual 30 sec | Procedure or surgery | slow sternal retraction |
Primary outcome
Incidence of chronic post-sternotomy pain
Time frame: 6 months postoperatively
incidence of chronic post-sternotomy pain 6 months following coronary artery bypass graft surgery
7 secondary outcomes
Incidence of chronic post-sternotomy pain
Time frame: 3 and 12 months postoperatively
severity of chronic postoperative pain
Time frame: 3 months. 6 months, 1 year
severity of acute postoperative pain at rest and with coughing
Time frame: daily while an inpatient up to 1 week postoperatively
analgesic consumption
Time frame: daily while an inpatient up to 1 week postoperatively, 1 week postoperatively, 3, 6 and 12 months postoperatively
quality of life with the Modified Brief Pain Inventory (BPI)
Time frame: 3, 6, 12 months postoperatively
pain quality with the Douleur Neuropathique Questionnaire (DN4)
Time frame: 3, 6 and 12 months postoperatively
pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)
Time frame: 3, 6 and 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 38042399Phelan R, Petsikas D, Shelley J, Hopman WM, DuMerton D, Parry M, Payne D, Allard R, Cummings M, Parlow JL, Tanzola R, Wang LTS, Stewart C, Saha TK. Retraction speed and chronic poststernotomy pain: A randomized controlled trial. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1560-1567.e1. doi: 10.1016/j.jtcvs.2023.11.037. Epub 2023 Nov 30.
- Individual participant dataSharing planned: No
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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.
Tarit Saha, MD, FRCPC principal investigator
Queen's University/Kingston General Hospital
Dimitri Petsikas, MD, FRCSC principal investigator
Queen's University/ Kingston General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing slow sternal retraction in people with Chronic Pain, run by Dr. Tarit Saha at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of chronic post-sternotomy pain (time frame: 6 months postoperatively). 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 NCT02697812, which also lists 1 linked publication.
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 6 May 2023.