NCT07794527

Brief Summary

In cardiac surgery patients , effective pain control is crucial to support early extubation, mobilization, and cognitive recovery, yet systemic opioids carry substantial risks such as respiratory depression, delirium, and delayed rehabilitation. While regional fascial plane blocks offer a safer, opioid-sparing alternative, no single technique provides complete analgesia for the complex and multi-dermatomal pain generated by sternotomy, graft harvesting, chest wall retraction, and drain sites. Therefore, a multimodal approach combining blocks such as parasternal nerve block , rectus sheath nerve block and femoral nerve block , may cover most of areas expected to be sources of intraoperative and post-operative pain in cardiac surgery patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Sep 2026Apr 2027

First Submitted

Initial submission to the registry

April 2, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2027

Last Updated

August 31, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 2, 2026

Last Update Submit

August 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to Extubation

    Defined as the interval (in hours) from transferal to ICU to successful tracheal extubation

    from transferal to ICU until successful tracheal extubation assessed during post operative ICU stay up to 48 hours

Study Arms (2)

Group A (intervention)

ACTIVE COMPARATOR

Patients in this group will receive standardized general anaesthesia with a preemptive bilateral superficial parasternal nerve block using 20 mL of 0.25% bupivacaine per side, in combination with a rectus sheath block (RSB) using 10 mL of 0.25% bupivacaine per side. and femoral nerve block at the side of harvesting using 10 mL of 0.25% bupivacaine.

Procedure: regional nerve block with local anesthesia

Group B ( control)

PLACEBO COMPARATOR

Patients will receive standardized general anesthesia with placebo (saline) injections administered in the same anatomical planes.

Procedure: Placebo

Interventions

Patients will receive bilateral superficial parasternal nerve block using 20 mL of 0.25% bupivacaine per side, in combination with a rectus sheath block (RSB) using 10 mL of 0.25% bupivacaine per side. and femoral nerve block at the side of harvesting using 10 mL of 0.25% bupivacaine.

Group A (intervention)
PlaceboPROCEDURE

Patients will receive placebo (saline) injections administered in the same anatomical planes.

Group B ( control)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • o Scheduled for elective off-pump coronary artery bypass graft (OPCAB) surgery via median sternotomy
  • American Society of Anesthesiologists (ASA) physical status III - IV
  • Ability to provide informed consent

You may not qualify if:

  • o Emergency or redo cardiac surgery
  • On-pump CABG or concomitant valve or aortic procedures
  • Known allergy to local anesthetics or study drugs
  • Coagulopathy or ongoing anticoagulant therapy contraindicating regional block
  • Preoperative chronic opioid use or opioid dependency
  • Neurologic or psychiatric conditions interfering with pain assessment
  • Infection at the block injection site
  • Severe hepatic or renal impairment
  • Body mass index (BMI) \> 40 kg/m²
  • Inability to understand or cooperate with pain scoring or postoperative care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Sherif S Sultan, MD

    faculty of medicine Ain Shams university

    STUDY DIRECTOR

Central Study Contacts

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

April 2, 2026

First Posted

August 31, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 7, 2027

Last Updated

August 31, 2026

Record last verified: 2026-04

Locations