NCT07622823

Brief Summary

The aim of the present study is to evaluate the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in patients undergoing cardiac surgery.

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 all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

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 Progress8%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 26, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

cardiovascular surgerypectoral-intercostal fascial plane blockrecto-intercostal fascial plane blockrectus sheath blockpostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • postoperative opioid consumption

    48 hours

Secondary Outcomes (3)

  • postoperative recovery quality

    24 hours

  • postoperative pain scores

    48 hours

  • chronic pain

    3 months

Study Arms (3)

PIFPB+RIFPB

Other: PIFPB + RIFPB

PIFPB+RSB

Other: PIFPB + RSB

Control

Other: Control

Interventions

The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.

PIFPB+RIFPB

The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.

PIFPB+RSB
ControlOTHER

Regional anesthesia is not applied.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is planned to include ASA score I-IIII adult patients who are scheduled to elective cardiac surgery

You may qualify if:

  • elective cardiac surgery planned
  • over 18 years, adult
  • American Society of Anaesthesiology (ASA) score I-III

You may not qualify if:

  • under 18 years of age,
  • ASA IV and above,
  • contraindications for the block application
  • history of cardiac surgery,
  • reoperated due to surgery-related complications after emergency surgery or postoperative elective surgery,
  • off-pump cardiac surgery or minimally invasive cardiac surgery
  • unable to be extubated in the intensive care unit at 24 hours postoperatively
  • history of chronic pain treatment
  • chronic alcoholism and substance abuse
  • declining to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Grant MC, Gregory AJ, Ouanes JP. Regional analgesia for cardiac surgery. Curr Opin Anaesthesiol. 2022 Oct 1;35(5):605-612. doi: 10.1097/ACO.0000000000001169. Epub 2022 Jul 27.

    PMID: 35900740BACKGROUND
  • Ciftci B, Omur B, Alver S, Akin AN, Yildiz Y, Tulgar S. The Medipol Combination: Novel Rectointercostal Fascial Plane Block and Pectointercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery: A Report of 15 Cases. A A Pract. 2024 Jun 5;18(6):e01794. doi: 10.1213/XAA.0000000000001794. eCollection 2024 Jun 1.

    PMID: 38836555BACKGROUND

Study Officials

  • Arzu Karaveli

    University of Health Sciences, Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Ceren Nida Kural

    University of Health Sciences, Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 3, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations