NCT07716943

Brief Summary

Cardiopulmonary bypass surgery is associated with significant postoperative pain, which may adversely affect respiratory function, delay mobilization, prolong hospital stay, and increase postoperative complications. Within Enhanced Recovery After Surgery (ERAS) protocols, multimodal analgesia and opioid-sparing strategies have become essential components of perioperative care. Ultrasound-guided fascial plane blocks, including the anterior serratus plane block (ASPB) and pectoral-intercostal plane block (PIPB), have emerged as effective and safe regional anesthesia techniques for cardiac surgery, targeting different sensory innervation of the thoracic wall. However, evidence regarding the combined use of these two blocks remains limited. This study aimed to evaluate whether the combination of ASPB and PIPB improves intraoperative and postoperative analgesia, reduces opioid consumption, and enhances postoperative recovery and ERAS outcomes compared with standard analgesic management in patients undergoing cardiopulmonary bypass surgery.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
11mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress9%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

June 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

June 28, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Cardiopulmonary BypassPostoperative PainRegional AnesthesiaEnhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity

    Postoperative pain intensity will be assessed at rest and during coughing using the Visual Analog Scale at extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery. The Visual Analog Scale ranges from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.

Secondary Outcomes (10)

  • Intraoperative fentanyl consumption

    From induction of anesthesia until the end of surgery.

  • Postoperative tramadol consumption

    During the first 24 hours after surgery.

  • Time to extubation

    From the end of surgery until extubation, assessed up to 7 days after surgery.

  • Intensive care unit length of stay

    From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 30 days after surgery.

  • Hospital length of stay

    From the date of surgery until hospital discharge, assessed up to 30 days after surgery.

  • +5 more secondary outcomes

Study Arms (2)

GroupASPB + PIPB Group

EXPERIMENTAL

Patients in this group received ultrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block after induction of general anesthesia and before surgical incision as part of the multimodal analgesia protocol.

Procedure: Combined ASPB and PIPB

ASPB Group:

ACTIVE COMPARATOR

Patients assigned to the ASPB group underwent ultrasound-guided bilateral anterior serratus plane block following induction of general anesthesia and prior to skin incision. The block was incorporated into the perioperative multimodal analgesia protocol.

Procedure: Anterior Serratus Plane Block

Interventions

Ultrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block performed after induction of general anesthesia and before surgical incision to provide perioperative multimodal analgesia in patients undergoing cardiopulmonary bypass surgery.

GroupASPB + PIPB Group

Ultrasound-guided bilateral anterior serratus plane block performed after induction of general anesthesia and before surgical incision to provide perioperative analgesia in patients undergoing cardiopulmonary bypass surgery.

ASPB Group:

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing open heart surgery via median sternotomy by the Cardiovascular Surgery Clinic
  • Patients over 18 years of age
  • ASA II-III patients

You may not qualify if:

  • \- Patients undergoing emergency or recurrent surgery
  • Patients with left ventricular ejection fraction \< 30
  • Patients who died per-operatively
  • Patients who do not provide informed consent
  • Presence of chronic pain
  • Presence of allergy to local anesthetics
  • Presence of infection in the area where the block will be performed
  • Coagulopathy
  • Pre-existing neurological deficit
  • Mental retardation
  • Anatomical deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • LEYLA KILINC

    şişli etfal eğitim araştırma hastanesi

    STUDY CHAIR

Central Study Contacts

MUSTAFA ALTINAY

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
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 28, 2026

First Posted

July 21, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations