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Does the Speed of Sternal Retraction Affect Postoperative Pain Outcomes

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
slow sternal retraction
Sponsored by
Dr. Tarit Saha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

slow sternal retraction

standard sternal retraction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of chronic post-sternotomy pain
incidence of chronic pain
severity of chronic postoperative pain
pain on NRS scale
severity of acute postoperative pain at rest and with coughing
pain on NRS scale
analgesic consumption
quality of life with the Modified Brief Pain Inventory (BPI)
pain quality with the Douleur Neuropathique Questionnaire (DN4)
pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)

Full Information

First Posted
December 3, 2015
Last Updated
May 2, 2023
Sponsor
Dr. Tarit Saha
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1. Study Identification

Unique Protocol Identification Number
NCT02697812
Brief Title
Does the Speed of Sternal Retraction Affect Postoperative Pain Outcomes
Official Title
Does the Speed of Sternal Retraction During Coronary Artery Bypass Graft Surgery Affect Postoperative Pain Outcomes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Tarit Saha

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
slow sternal retraction
Arm Type
Experimental
Arm Description
sternal retraction (which is required for exposure of the heart during coronary artery bypass graft surgery) will be performed gradually over 15 minutes
Arm Title
standard sternal retraction
Arm Type
No Intervention
Arm Description
sternal retraction will be performed as per standard practice (sternum opened rapidly over 30 sec.)
Intervention Type
Procedure
Intervention Name(s)
slow sternal retraction
Other Intervention Name(s)
slow retraction
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of chronic post-sternotomy pain
Description
incidence of chronic post-sternotomy pain 6 months following coronary artery bypass graft surgery
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
Incidence of chronic post-sternotomy pain
Description
incidence of chronic pain
Time Frame
3 and 12 months postoperatively
Title
severity of chronic postoperative pain
Description
pain on NRS scale
Time Frame
3 months. 6 months, 1 year
Title
severity of acute postoperative pain at rest and with coughing
Description
pain on NRS scale
Time Frame
daily while an inpatient up to 1 week postoperatively
Title
analgesic consumption
Time Frame
daily while an inpatient up to 1 week postoperatively, 1 week postoperatively, 3, 6 and 12 months postoperatively
Title
quality of life with the Modified Brief Pain Inventory (BPI)
Time Frame
3, 6, 12 months postoperatively
Title
pain quality with the Douleur Neuropathique Questionnaire (DN4)
Time Frame
3, 6 and 12 months postoperatively
Title
pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)
Time Frame
3, 6 and 12 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarit Saha, MD, FRCPC
Organizational Affiliation
Queen's University/Kingston General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitri Petsikas, MD, FRCSC
Organizational Affiliation
Queen's University/ Kingston General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Does the Speed of Sternal Retraction Affect Postoperative Pain Outcomes

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