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

NCT ID: NCT06453681

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bupivacain

patients receive bilateral Pecs block with bupivacin 0.25%,

Group Type ACTIVE_COMPARATOR

bilateral PECS

Intervention Type OTHER

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

dexameditomedine bupivacain

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

Group Type ACTIVE_COMPARATOR

bilateral PECS

Intervention Type OTHER

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

Dexmedetomidine

Intervention Type 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

Interventions

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bilateral PECS

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

Intervention Type OTHER

Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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PECTORAL NERVE BLOCK precedex

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Mohamed Elhaddad

Assisstent professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasralainy school of medicine

Cairo, , Egypt

Site Status RECRUITING

Kasralaini Faculty of Medicine

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ahmed Elhaddad, MD

Role: primary

01224042847

Ahmed Elhaddad, MD

Role: primary

01224042847

Other Identifiers

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MD-75-2024

Identifier Type: -

Identifier Source: org_study_id

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