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Clinical Trials/NCT02697812
NCT02697812CompletedNot Applicable

Does the Speed of Sternal Retraction During Coronary Artery Bypass Graft Surgery Affect Postoperative Pain Outcomes: A Randomized Controlled Trial

Dr. Tarit Saha1 site in 1 country326 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
326
Locations
1
Primary Endpoint
Incidence of chronic post-sternotomy pain

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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

Arms & Interventions

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

Intervention: slow sternal retraction (Procedure)

standard sternal retraction

No Intervention

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • severity of chronic postoperative pain(3 months. 6 months, 1 year)
  • Incidence of chronic post-sternotomy pain(3 and 12 months postoperatively)
  • quality of life with the Modified Brief Pain Inventory (BPI)(3, 6, 12 months postoperatively)
  • pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)(3, 6 and 12 months postoperatively)
  • analgesic consumption(daily while an inpatient up to 1 week postoperatively, 1 week postoperatively, 3, 6 and 12 months postoperatively)
  • severity of acute postoperative pain at rest and with coughing(daily while an inpatient up to 1 week postoperatively)
  • pain quality with the Douleur Neuropathique Questionnaire (DN4)(3, 6 and 12 months postoperatively)

Investigators

Sponsor
Dr. Tarit Saha
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Tarit Saha

Principal Investigator

Queen's University

Study Sites (1)

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