NCT07522229

Brief Summary

This randomized controlled trial aims to compare the analgesic efficacy of parasternal intercostal plane block (PIPB) alone versus the combination of parasternal intercostal plane block and serratus anterior plane block (SAPB) in adult patients undergoing elective cardiac surgery via sternotomy. Seventy patients will be randomly assigned to two groups: Group A will receive bilateral PIPB, while Group B will receive bilateral PIPB combined with unilateral SAPB on the side of chest drain placement. Postoperative pain will be assessed using the visual analog scale (VAS) at rest and during movement over the first 24 hours. Secondary outcomes include time to extubation, length of stay in the intensive care unit, and time to mobilization. The study is designed as a prospective, single-center, single-blind trial conducted at Akdeniz University Hospital, Antalya, Turkey. We hypothesize that the combined block technique will provide superior analgesia, reduce opioid consumption, and improve recovery parameters compared to PIPB alone

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
1mo left

Started Oct 2025

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 Progress92%
Oct 2025May 2026

First Submitted

Initial submission to the registry

September 25, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

October 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

September 25, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

Parasternal Intercostal Plane BlockSerratus Anterior Plane BlockCardiac Surgery Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity (VAS)

    Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    24 hours after surgery

Secondary Outcomes (3)

  • Time to extubation

    Postoperative period until extubation.

  • Length of stay in the intensive care unit (ICU)

    From ICU admission after surgery until ICU discharge, up to 30 days

  • Time to first mobilization

    From ICU admission after surgery until the first mobilization attempt, assessed up to 30 days

Other Outcomes (2)

  • Number of rescue opioid administrations

    Within the first 24 hours after surgery

  • Total dose of rescue opioids

    Within the first 24 hours after surgery

Study Arms (2)

Parasternal Intercostal Plane Block

EXPERIMENTAL

Patients will receive bilateral parasternal intercostal plane block with bupivacaine under ultrasound guidance, plus standard intravenous morphine at the end of surgery.

Procedure: Parasternal Intercostal Plane BlockProcedure: Parasternal Intercostal Plane Block + Serratus Anterior Plane Block

Parasternal + Serratus Plane Block

EXPERIMENTAL

Patients will receive bilateral parasternal intercostal plane block combined with unilateral serratus anterior plane block (on the chest drain side), using bupivacaine under ultrasound guidance.

Procedure: Parasternal Intercostal Plane BlockProcedure: Parasternal Intercostal Plane Block + Serratus Anterior Plane Block

Interventions

Bilateral parasternal intercostal plane block will be performed as in Arm 1. In addition, a unilateral serratus anterior plane block will be performed under ultrasound guidance at the 4th-6th intercostal level on the side of chest drain placement, with 0.25% bupivacaine (5-7 mL per injection site, not exceeding 2.5 mg/kg).

Parasternal + Serratus Plane BlockParasternal Intercostal Plane Block

Bilateral parasternal intercostal plane block will be performed under ultrasound guidance at the 3rd and 5th intercostal spaces using 0.25% bupivacaine (total 30 mL). At the end of surgery, intravenous morphine (0.1 mg/kg) will be administered.

Parasternal + Serratus Plane BlockParasternal Intercostal Plane Block

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Konya Şehir Hastanesi

Konya, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Kuwano K, Kawasaki M, Maeyama T, Hagimoto N, Nakamura N, Shirakawa K, Hara N. Soluble form of fas and fas ligand in BAL fluid from patients with pulmonary fibrosis and bronchiolitis obliterans organizing pneumonia. Chest. 2000 Aug;118(2):451-8. doi: 10.1378/chest.118.2.451.

    PMID: 10936140BACKGROUND
  • Servidio AG, Capata G, Levantino L, Riccio G, Contorno S, Barbi E, Maschio M. COVID-19 lockdown beneficial effects on lung function in a cohort of cystic fibrosis patients. Ital J Pediatr. 2021 Jan 18;47(1):12. doi: 10.1186/s13052-021-00970-4. No abstract available.

    PMID: 33461569BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • BEDİA MİNE HANEDAN

    Konya şehir hastanesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BEDİA MİNE HANEDAN

CONTACT

BULENT HANEDAN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2025

First Posted

April 13, 2026

Study Start

October 5, 2025

Primary Completion

April 5, 2026

Study Completion (Estimated)

May 5, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations