Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

Phase 3

Completed

• Conditions: Coronary Artery Bypass Graft Surgery
• Interventions: Drug: Standard of care; Drug: Parasternal blocks

• Registration Number: NCT05191745
• Lead Sponsor: Jewish General Hospital

Brief Summary

This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.

Detailed Description

This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-13
• Study Start: 2022-01-26
• Primary Completion: 2023-04-28
• Status Verified: 2024-06
• Study Completion: 2024-06-01
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery.

Exclusion Criteria

• Patients with a history of regular opioid use.
• Patients with a history of chronic pain.
• Patients unable to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard of care	Patients will receive all standard care as per the hospital protocols.
Intervention group	Parasternal blocks	Patients will receive bilateral parasternal blocks at the end of cardiac surgery.

Primary Outcome Measures

Name	Time	Method
Pain with inspirometry at 24 hours after surgery	24 hours after surgery	Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"

Secondary Outcome Measures

Name	Time	Method
Pain score with inspirometry	12 and 48 hours after surgery	Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Patient satisfaction with pain control	at 48 hours after surgery	0 "extremely unsatisfied" to 10 "extremely satisfied"
Amount of rescue analgesia administered	Total in the first 48 hours after surgery	Amount of ketorolac or ketamine administered
Intensive Care Unit (ICU) Length of Stay	From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study	Time spent in the intensive care unit after surgery (days)
Hospital Length of Stay	From the date of surgery up until discharge from hospital, followed from the date of surgery up until 6 months after the completion of the study	Time spent in the hospital after surgery (days)
Pain score at rest	12, 24 and 48 hours after surgery	Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Inspirometry	24 hours after surgery	Volume inspired on inspirometry
Mobilization	From ICU arrival until first mobilization (approximately first 48 hours postoperatively)	Time from ICU arrival to the first mobilization to a chair
Opioid consumption	12, 24 and 48 hours after surgery	Amount of opioid administered (mg of Dilaudid)
Ambulation	From ICU arrival until first ambulation (approximately first 72 hours postoperatively)	Time from ICU arrival to the first mobilization to a chair

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada