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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05191745
Other study ID # 2022-3125
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 26, 2022
Est. completion date June 1, 2024

Study information

Verified date March 2024
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date June 1, 2024
Est. primary completion date April 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms

  • Coronary Artery Bypass Graft Surgery

Intervention

Drug:
Parasternal blocks
Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg
Standard of care
All standard management of postoperative pain, as per local protocols

Locations

Country Name City State
Canada Jewish General Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Presence of postoperative vomiting Vomiting after surgery first 48 hours after surgery
Other Incidence of bradycardia Heart rate less than 60 beats per minute first 48 hours after surgery
Other Incidence of hyperglycemia Glucose greater than 10 millimoles/liter first 48 hours after surgery
Other Incidence of a pneumothorax Pneumothorax identified on chest x-ray first 48 hours after surgery
Other Local anesthetic toxicity Local anesthetic toxicity, as diagnosed clinically first 48 hours after surgery
Other Postoperative Delirium Delirium as defined by the "Confusion assessment method for the ICU" (CAM-ICU) first 48 hours after surgery
Other Narcotic prescription on discharge Having a narcotic prescription on discharge Upon discharge from hospital after surgery (approximately 1 week after surgery)
Other Sternal pain at 3 months Persistent pain at the sternum Three months after the day of surgery
Other Local anesthetic spread Number of levels of spread of local anesthetic, as identified by ultrasound Immediately as intervention is performed
Primary 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 Opioid consumption Amount of opioid administered (mg of Dilaudid) 12, 24 and 48 hours after surgery
Secondary Amount of rescue analgesia administered Amount of ketorolac or ketamine administered Total in the first 48 hours after surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Inspirometry Volume inspired on inspirometry 24 hours after surgery
Secondary Patient satisfaction with pain control 0 "extremely unsatisfied" to 10 "extremely satisfied" at 48 hours after surgery
Secondary Mobilization Time from ICU arrival to the first mobilization to a chair From ICU arrival until first mobilization (approximately first 48 hours postoperatively)
Secondary Ambulation Time from ICU arrival to the first mobilization to a chair From ICU arrival until first ambulation (approximately first 72 hours postoperatively)
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