NCT07417462

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 11, 2026

Last Update Submit

February 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total amount analgesic requirement

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

    24 hours postoperatively

Secondary Outcomes (8)

  • Degree of pain

    24 hours postoperatively

  • The number of patients required rescue analgesia

    24 hours postoperatively

  • Postoperative nausea and vomiting (PONV)

    24 hours postoperatively

  • Time to extubation

    24 hours postoperatively

  • Length of stay in the intensive care unit.

    Average 7 days postoperatively

  • +3 more secondary outcomes

Study Arms (3)

Group PIFB

EXPERIMENTAL

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

EXPERIMENTAL

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

SHAM COMPARATOR

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)

Interventions

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

Group PIFB

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

Group TTPB

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.

Control Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Noha H Abdelghany, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia & ICU, Faculty of Medicine, Assiut University

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations