Does the Speed of Sternal Retraction Affect Postoperative Pain Outcomes

NCT02697812 | Completed DMC

• 1 other identifier: ANAE-233-13
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic post-sternotomy pain

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

  6 months postoperatively

Secondary Outcomes (7)

• Incidence of chronic post-sternotomy pain

  3 and 12 months postoperatively

• severity of chronic postoperative pain

  3 months. 6 months, 1 year

• severity of acute postoperative pain at rest and with coughing

  daily while an inpatient up to 1 week postoperatively

• analgesic consumption

  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)

  3, 6, 12 months postoperatively

Study Arms (2)

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

Procedure: slow sternal retraction

standard sternal retraction

NO INTERVENTION

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

Interventions

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

Also known as: slow retraction

slow sternal retraction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Tarit Saha: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tarit Saha, MD, FRCPC

  Queen's University/Kingston General Hospital

  PRINCIPAL INVESTIGATOR

• Dimitri Petsikas, MD, FRCSC

  Queen's University/ Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: March 3, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)