Skip to main content
OpenTrials
Completed

NCT Number: NCT02697812

Does the Speed of Sternal Retraction Affect Postoperative Pain Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

slow sternal retraction

Procedure

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

Other names: slow retraction

Primary outcomes

  1. 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

  1. Incidence of chronic post-sternotomy pain

    Time frame: 3 and 12 months postoperatively

    incidence of chronic pain

  2. severity of chronic postoperative pain

    Time frame: 3 months. 6 months, 1 year

    pain on NRS scale

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

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

    pain on NRS scale

  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

Sponsors and collaborators

Lead sponsor

Dr. Tarit Saha

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Mar 3, 2016
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.