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CompletedNCT07417462ClinicalTrials.gov record

Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery

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

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
40 years - 60 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
90 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.
Understand screening

Treatment, groups and participation

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Assignment
Random assignment
Masking
Double masked
Group PIFB

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

Other: Pecto-intercostal fascial block

Group TTPB

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

Other: Transversus thoracic muscle plane block

Control Group

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.

Other: Sham (No Treatment)

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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 measures

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.

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.

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.

Time to extubation

Time frame: 24 hours postoperatively

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

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.

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.

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).

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

Assiut UniversityAsyut, Asyut Governorate, EgyptStatus unknown

Study team and timeline

Lead sponsor
Assiut University
Study start
Feb 18, 2026 Actual
Primary completion
Aug 1, 2026 Actual
Study completion
Sep 1, 2026 Actual
First posted
Feb 18, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026