Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral PECs for Pain Control After Cardiac Surgeries

Post Operative Pain Clinical Trial

— PECs  

Official title:

Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral Pectoral Nerve Blocks for Postoperative Pain Control After Cardiac Surgeries: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453681
• Other study ID #: MD-75-2024
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

Description:

Background: Good postoperative analgesia in cardiac surgical patients helps in early recovery and ambulation. An alternative to parenteral, paravertebral, and thoracic epidural analgesia can be pectoralis nerve (Pecs) block, which is a novel, less invasive regional analgesic technique.

The study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

sixty adult patients between the age groups of 25 and 65 years undergoing coronary artery bypass grafting or valve surgeries through midline sternotomy under general anesthesia were enrolled in the study. Patients were randomly allocated into two groups with 30 ineach group. Group 1 patients will receive bilateral Pecs block, whereas Group 2 patients will receive bilateral Pecs block with dexameditomedine postoperatively. Patients will be extubated once they fulfilled extubation criteria. Ventilator duration will be recorded. Patients will be interrogated for pain by visual analog scale (VAS) scoring at rest and cough. Inspiratory flow rate will be assessed using incentive spirometry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• All adult patients between the age groups of 25 and 65 years undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy under general anesthesia

Exclusion Criteria:

• Skin erosions, hematomas or infection at the injection site.

• coagulopathy, ACT more than 150 seconds

• History of hypersensitivity to bupivacaine or Dexametomedine.

• The Patients who are unable to use the pain score.

• patients who will need prolonged post-operative ventilation or inotropic support.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• bilateral PECS
ectoralis nerve (Pecs) block, which is novel, less invasive regional analgesic technique.

Drug:
• Dexmedetomidine
Dexmedetomidine is a potent a2 agonist. In our practice, dexmedetomidine is administered as an additive to regional anesthesia to improve the duration and quality of analgesia

Locations

Country	Name	City	State
Egypt	Kasralaini Faculty of Medicine	Cairo
Egypt	Kasralainy school of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of analgesia	from block start time (time of LA injection) to block end time at which VAS score 4 or more)	up to 24 hour