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Recruiting NCT07417462

Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery

No phase Interventional Transversus Thoracic Muscle Plane Block Pecto-intercostal Fascial Block Enhanced Recovery Cardiac Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pecto-intercostal fascial block, Transversus thoracic muscle plane block, Sham (No Treatment).
Who it may be relevant to
Registry conditions: Transversus Thoracic Muscle Plane Block, Pecto-intercostal Fascial Block, Enhanced Recovery, Cardiac Surgery. Basic parameters: 40 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery. A Prospective, Randomized, Study

Overview

This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries

Detailed description

In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.

The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.

Interventions

  • Other Pecto-intercostal fascial block
    Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
  • Other Transversus thoracic muscle plane block
    Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
  • Other Sham (No Treatment)
    Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially.

Primary outcome measures

  • Total amount analgesic requirement [Time frame: 24 hours postoperatively]
Secondary outcome measures (8)
  • Degree of pain [Time frame: 24 hours postoperatively]
  • The number of patients required rescue analgesia [Time frame: 24 hours postoperatively]
  • Postoperative nausea and vomiting (PONV) [Time frame: 24 hours postoperatively]
  • Time to extubation [Time frame: 24 hours postoperatively]
  • Length of stay in the intensive care unit. [Time frame: Average 7 days postoperatively]
  • Assessment of Delirium [Time frame: 24 hours postoperatively]
  • Level of patient satisfaction [Time frame: 24 hours postoperatively]
  • Incidence of complications. [Time frame: 7 days postoperatively]

Eligibility criteria

Inclusion criteria

  • Age from 40 to 60 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status II-III.
  • Body mass index (BMI) < 35 kg/m2.
  • Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).

Exclusion criteria

  • Valve replacement procedures.
  • Emergency operations.
  • Redo surgeries.
  • Minimally invasive approaches.
  • The presence of psychiatric disorders.
  • Cognitive impairment preventing accurate assessment using the verbal numerical rating scale (NRS).
  • Known hypersensitivity or a history of allergy to local anesthetics.
  • Had severe major organ dysfunction.
  • Left ventricular ejection fraction below 30%.
  • Pregnancy or breastfeeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut University — Asyut

Identifiers

NCT: NCT07417462 · 04-2026-300788

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗