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

NCT06453681 | Completed Phase 4 DMC

• 1 other identifier: MD-75-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Operative Pain

Keywords

PECs; dexameditomedine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

bupivacain

ACTIVE COMPARATOR

patients receive bilateral Pecs block with bupivacin 0.25%,

Other: bilateral PECS

dexameditomedine bupivacain

ACTIVE COMPARATOR

patients received bilateral Pecs block with bupivacin 0.25% plus dexmedetomidine 0.5 μg/Kg as adjuvant.

Other: bilateral PECS; Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine is a potent α2 agonist. In our practice, dexmedetomidine is administered as an additive to regional anesthesia to improve the duration and quality of analgesia

Also known as: precedex

dexameditomedine bupivacain

bilateral PECS OTHER

ectoralis nerve (Pecs) block, which is novel, less invasive regional analgesic technique.

Also known as: PECTORAL NERVE BLOCK

bupivacain; dexameditomedine bupivacain

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (2)

Kasralainy school of medicine

Cairo, 11954, Egypt

Location

Kasralaini Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstent professor

Model Details: randomized controlled study

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 12, 2024
• Study Start: August 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 2, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)