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CompletedNCT02697812Updated May 6, 2023

Does the Speed of Sternal Retraction Affect Postoperative Pain Outcomes

An interventional study of slow sternal retraction in Chronic Pain, sponsored by Dr. Tarit Saha. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Dr. Tarit Saha · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2014, registered Dec 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
326
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 326 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Dr. Tarit Saha is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • elective coronary artery bypass graft surgery
  • understand written informed consent
  • ASA I,II or III

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
326 participants (actual)

Study arms

  • Experimental
    slow sternal retraction

    sternal retraction (which is required for exposure of the heart during coronary artery bypass graft surgery) will be performed gradually over 15 minutes

    Procedure: slow sternal retraction

  • No intervention
    standard sternal retraction

    sternal retraction will be performed as per standard practice (sternum opened rapidly over 30 sec.)

Interventions

  • Procedureslow sternal 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

    Also known as: slow retraction

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What researchers measure

Primary outcomes

  1. Incidence of chronic post-sternotomy pain

    incidence of chronic post-sternotomy pain 6 months following coronary artery bypass graft surgery

    Time frame: 6 months postoperatively

Secondary outcomes

  1. Incidence of chronic post-sternotomy pain

    incidence of chronic pain

    Time frame: 3 and 12 months postoperatively

  2. severity of chronic postoperative pain

    pain on NRS scale

    Time frame: 3 months. 6 months, 1 year

  3. severity of acute postoperative pain at rest and with coughing

    pain on NRS scale

    Time frame: daily while an inpatient up to 1 week postoperatively

  4. analgesic consumption

    Time frame: daily while an inpatient up to 1 week postoperatively, 1 week postoperatively, 3, 6 and 12 months postoperatively

  5. quality of life with the Modified Brief Pain Inventory (BPI)

    Time frame: 3, 6, 12 months postoperatively

  6. pain quality with the Douleur Neuropathique Questionnaire (DN4)

    Time frame: 3, 6 and 12 months postoperatively

  7. pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)

    Time frame: 3, 6 and 12 months postoperatively

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Study locations

1 site
  • Kingston General Hospital
    Kingston, Ontario K7L 2V7, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02697812
Lead sponsor
Dr. Tarit Saha
Responsible party
Dr. Tarit Saha (Principal Investigator, Kingston Health Sciences Centre) — Sponsor-investigator
First posted
Mar 3, 2016
Start date
Jan 2014
Primary completion
Dec 2019
Completion
Dec 2020
Last update
May 6, 2023

Study contacts

Tarit Saha, MD, FRCPC
principal investigator · Queen's University/Kingston General Hospital
Dimitri Petsikas, MD, FRCSC
principal investigator · Queen's University/ Kingston General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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