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

Phase 4

Recruiting

• Conditions: Post Operative Pain
• Interventions: Other: bilateral PECS; Drug: Dexmedetomidine

• Registration Number: NCT06453681
• Lead Sponsor: Kasr El Aini Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-12
• Study Start: 2024-08-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexameditomedine bupivacain	bilateral PECS	patients received bilateral Pecs block with bupivacin 0.25% plus dexmedetomidine 0.5 μg/Kg as adjuvant.
dexameditomedine bupivacain	Dexmedetomidine	patients received bilateral Pecs block with bupivacin 0.25% plus dexmedetomidine 0.5 μg/Kg as adjuvant.
bupivacain	bilateral PECS	patients receive bilateral Pecs block with bupivacin 0.25%,

Primary Outcome Measures

Name	Time	Method
The duration of analgesia	up to 24 hour	from block start time (time of LA injection) to block end time at which VAS score 4 or more)

Trial Locations

Locations (2)

Kasralainy school of medicine; 🇪🇬 Cairo, Egypt

Kasralaini Faculty of Medicine; 🇪🇬 Cairo, Egypt