Dexmedetomidine Combined With Bupivacaine in Ultrasound-guided Pecto-Intercostal Fascial Block in Cardiac Surgery

NCT07023874 | Not Yet Recruiting

• 1 other identifier: 0108877
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recent advancements in pain management techniques suggest that ultrasound-guided peripheral nerve blocks may significantly benefit patients undergoing cardiac surgery. One noteworthy approach is the interfascial thoracic wall plane block, which has become an essential element of multimodal analgesia for post-cardiac surgery care. The pecto-intercostal fascial plane block (PIFPB) is a technique that utilizes ultrasound guidance to administer local anesthetic (LA) into the space between the intercostal muscles and the pectoralis major muscle. This intervention targets the anterior cutaneous branches of the thoracic nerves, particularly T2-T6, which are responsible for sensation in the anteromedial chest wall, including the sternum. Interestingly, the potential role of dexmedetomidine in improving the quality and prolonging the duration of analgesia for post-sternotomy pain through the pecto-intercostal fascial plane block remains unexamined in the current literature, indicating an area ripe for further research.

Conditions

Postoperative Pain; Cardiac Surgery

Keywords

pectointercostal fascial plain block; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• amount of opioid consumption at 24 hours after ICU admission

  Postoperative total fentanyl consumption: total dose of fentanyl (µg/kg) administered postoperatively during the first postoperative 24 h after ICU admission.

  24 hours after ICU admission

Secondary Outcomes (4)

• time to extubation

  6 hours after ICU admiision

• the intensity of postoperative pain at rest and upon coughing

  24 hours after extubation

• time to first rescue analgesia

  24 hour after ICU admission

• patient satisfaction

  24 hour after ICU admission

Study Arms (2)

bupivacaine only in pectointercostal fascial plain block

ACTIVE COMPARATOR

Participants will receive bilateral ultrasound-guided pecto-intercostal fascial plane block using 30 mL of 0.25% bupivacaine on each side

Procedure: Bupivacaine group

bupivacaine and dexmedetomidine in pectointercostal fascial plain block

EXPERIMENTAL

Participants will receive bilateral ultrasound-guided pecto intercostal fascial plane block using 30 mL of 0.25% bupivacaine with one µg/kg dexmedetomidine on each side.

Procedure: bupivacaine + dexmedetomidine group

Interventions

Bupivacaine group PROCEDURE

Participants will receive bilateral ultrasound-guided pecto-intercostal fascial plane block

bupivacaine only in pectointercostal fascial plain block

bupivacaine + dexmedetomidine group PROCEDURE

Participants will receive bilateral ultrasound-guided pecto intercostal fascial plane block using 30 mL of 0.25% bupivacaine with one µg/kg dexmedetomidine in each side

bupivacaine and dexmedetomidine in pectointercostal fascial plain block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years.
• Both sexes.
• ASA physical status class II or III.
• Elective fast-tracking on-pump cardiac surgery.

You may not qualify if:

• The patient refused to participate in the study.
• Cognitive impairment or mental disorders.
• Hepatic and renal impairment.
• Congestive heart failure.
• Urgent/emergent surgery.
• BMI \<18 and \>35 (kg/m2).
• Documented allergy to local anaesthetics or dexmedetomidine.
• Use of chronic pain medications.
• Previous sternotomy or chest surgery.
• Patients with a history of substance abuse.
• Requires the use of mechanical circulatory support pre-operatively.
• Patients who will not be candidates for fast-tracking extubation after block administration.

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ISLAM MOHAMMED ELBARDAN, MD

CONTACT

0020 1112278083; Islam.elbardan@Alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER OF ANESTHESIA AND SURGICALMINTENSIVE CARE

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share