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NCT Number: NCT07417462

Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery

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

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Key information

Conditions

Transversus Thoracic Muscle Plane Block Cardiac Surgery Enhanced Recovery Pecto-intercostal Fascial Block

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, 71515, Egypt

Location status: Recruiting

Location contact

Abdelrahman H Mohammed, MD

PRINCIPAL_INVESTIGATOR

Ahmed S Imbaby, MD

PRINCIPAL_INVESTIGATOR

Noha H Abdelghany, MD

CONTACT

[email protected]

+966545945924

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pecto-intercostal fascial block

Other

Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).

Transversus thoracic muscle plane block

Other

Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).

Sham (No Treatment)

Other

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 outcomes

  1. Total amount analgesic requirement

    Time frame: 24 hours postoperatively

    In cases where rescue analgesia is required [numerical rating scale (NRS) ≥4], intravenous Nalbuphine 0.1 mg/kg will be given.

Secondary outcomes

  1. Degree of pain

    Time frame: 24 hours postoperatively

    Degree of pain will be assessed using Numerical rating scale (NRS) from 0 (no pain) to 10 (worst severe pain). NRS will be measured at 2h, 4h, 8h, 16h and 24h after surgery.

  2. The number of patients required rescue analgesia

    Time frame: 24 hours postoperatively

    The number of patients requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.

  3. Postoperative nausea and vomiting (PONV)

    Time frame: 24 hours postoperatively

    The patients will be verbally evaluated according to a descriptive five-point postoperative nausea and vomiting (PONV) scale at 0, 3, 6, 12, 18, and 24 hours after the extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.

  4. Time to extubation

    Time frame: 24 hours postoperatively

    After the operation, the time until the patient is extubated will be recorded.

  5. Length of stay in the intensive care unit.

    Time frame: Average 7 days postoperatively

    The time from admission to the intensive care unit (ICU) to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days. Total duration of stay in ICU will be recorded.

  6. Assessment of Delirium

    Time frame: 24 hours postoperatively

    Delirium will be assessed using the 3-minute diagnostic Confusion Assessment Method (CAM) (acute, inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. Delirium using the 3-minute diagnostic Confusion Assessment Method ( acute , inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. It will be evaluated 24 hrs after extubation.

  7. Level of patient satisfaction

    Time frame: 24 hours postoperatively

    Level of patient satisfaction estimated by a 5-point Likert scale (1:extremely dissatisfied; 2: unsatisfied; 3: neutral; 4: satisfied; 5: extremely satisfied).

  8. Incidence of complications.

    Time frame: 7 days postoperatively

    Any complications-directly related to the block or the drug used in the block- will be recorded. Complications can include local anesthetic toxicity, vascular injury, pneumothorax, failed block, and anaphylactic shock.

Study contacts

Contact information is provided by the study sponsor or research team.

Noha H Abdelghany, MD

CONTACT

[email protected]

+966545945924

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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