Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery: A Randomized, Controlled, Double-Blinded Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Bypass Graft Surgery
• Intervention / Treatment: Drug: Parasternal blocks; Drug: Standard of care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Patients will receive bilateral parasternal blocks at the end of cardiac surgery.	Drug: Parasternal blocks; Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg; Other Names: pecto-intercostal fascial blocks
Placebo Comparator: Control group; Patients will receive all standard care as per the hospital protocols.	Drug: Standard of care; All standard management of postoperative pain, as per local protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with inspirometry at 24 hours after surgery	Visual analog scale (VAS) 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"	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Amount of opioid administered (mg of Dilaudid)	12, 24 and 48 hours after surgery
Amount of rescue analgesia administered	Amount of ketorolac or ketamine administered	Total in the first 48 hours after surgery
Pain score at rest	Visual analog scale (VAS) 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"	12, 24 and 48 hours after surgery
Pain score with inspirometry	Visual analog scale (VAS) 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"	12 and 48 hours after surgery
Intensive Care Unit (ICU) Length of Stay	Time spent in the intensive care unit after surgery (days)	From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study
Hospital Length of Stay	Time spent in the hospital after surgery (days)	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
Inspirometry	Volume inspired on inspirometry	24 hours after surgery
Patient satisfaction with pain control	0 "extremely unsatisfied" to 10 "extremely satisfied"	at 48 hours after surgery
Mobilization	Time from ICU arrival to the first mobilization to a chair	From ICU arrival until first mobilization (approximately first 48 hours postoperatively)
Ambulation	Time from ICU arrival to the first mobilization to a chair	From ICU arrival until first ambulation (approximately first 72 hours postoperatively)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of postoperative vomiting	Vomiting after surgery	first 48 hours after surgery
Incidence of bradycardia	Heart rate less than 60 beats per minute	first 48 hours after surgery
Incidence of hyperglycemia	Glucose greater than 10 millimoles/liter	first 48 hours after surgery
Incidence of a pneumothorax	Pneumothorax identified on chest x-ray	first 48 hours after surgery
Local anesthetic toxicity	Local anesthetic toxicity, as diagnosed clinically	first 48 hours after surgery
Postoperative Delirium	Delirium as defined by the "Confusion assessment method for the ICU" (CAM-ICU)	first 48 hours after surgery
Narcotic prescription on discharge	Having a narcotic prescription on discharge	Upon discharge from hospital after surgery (approximately 1 week after surgery)
Sternal pain at 3 months	Persistent pain at the sternum	Three months after the day of surgery
Local anesthetic spread	Number of levels of spread of local anesthetic, as identified by ultrasound	Immediately as intervention is performed

Collaborators and Investigators

• Sponsor: Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Cardiac surgery
• Other Study ID Numbers: 2022-3125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No