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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06453681
Other study ID # MD-75-2024
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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