Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients

NCT05323305 | Unknown DMC

• 1 other identifier: 0305468
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.

Conditions

Pain, Post Operative

Keywords

Ultrasound, pectointercostal, Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• the analgesic effectiveness of the two blocks on midline sternotomy pain,

  Postoperative pain evaluation after extubation will be done using the Visual Analogue Scale (VAS). a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."

  from end of surgery till discharge from ICU (96 hours)

Secondary Outcomes (2)

• pulmonary complications

  from end of surgery till discharge from ICU (96 hours)

• length of stay in ICU

  average 4 days

Study Arms (2)

Pectointercostal Group (n=30)

ACTIVE COMPARATOR

They will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care.

Procedure: ultrasound guided regional block

Transversus thoracic Group (n=30)

ACTIVE COMPARATOR

They will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care.

Procedure: ultrasound guided regional block

Interventions

ultrasound guided regional block PROCEDURE

Bupivacaine injection by the use of ultrasound in the pectointercostal fascial plane in one group and in the trasversus thoracic plane in the other group.

Also known as: ultrasound guided nerve block

Pectointercostal Group (n=30); Transversus thoracic Group (n=30)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient.
• Elective cardiac surgery.

You may not qualify if:

• Refusal to participate.
• Redo or urgent cardiac surgery.
• Local infection of the skin at the site of needle puncture.
• Allergy to bupivacaine.
• Coagulation disorders.
• Clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension.
• when extubation is intentionally planned to be delayed

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Hospitals

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• islam Omar, MD

  Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university

  STUDY CHAIR

• Ibrahim Ibrahim, MD

  Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university

  PRINCIPAL INVESTIGATOR

• Moustafa Halwag, MD

  Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university

  STUDY DIRECTOR

Central Study Contacts

Islam Omar, MD

CONTACT

+201227851759; i_omar12@alexmed.edu.eg

Ibrahim Ibrahim, MD

CONTACT

01224336786

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: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 12, 2022
• Study Start: March 30, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately after publication No end date
• Access Criteria: Any one who wishes to access the data

Locations

EG (1)