Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

Coronary Artery Bypass Graft Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191745
• Other study ID #: 2022-3125
• Status: Completed
• Phase: Phase 3
• Start date: January 26, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2024
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• 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.

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	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"	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	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"	12, 24 and 48 hours after surgery
Secondary	Pain score with inspirometry	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"	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)