NCT07785323

Brief Summary

This prospective, randomized, controlled study aims to evaluate the effects of ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block on postoperative recovery and pain management in patients undergoing cardiac surgery. A total of 50 adult patients will be randomized into two groups: an SPSIP block group and a control group. The investigators will assess postoperative pain, opioid consumption, and quality of recovery during the postoperative period.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable

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 Progress7%
Aug 2026Feb 2027

First Submitted

Initial submission to the registry

August 10, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 10, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

Serratus Posterior Superior Intercostal Plane BlockSPSIP BlockQuality of RecoveryQoR-15QoR-15TPostoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Quality of Recovery Assessed by QoR-15T

    Postoperative quality of recovery will be assessed using the Turkish version of the Quality of Recovery-15 questionnaire (QoR-15T). The QoR-15T consists of 15 items assessing multiple dimensions of postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.

    Postoperative 24 hours

Secondary Outcomes (8)

  • Total Postoperative Tramadol Consumption

    From the end of surgery to postoperative 48 hours

  • Postoperative Pain Intensity

    Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours

  • Number of Participants With Postoperative Nausea and/or Vomiting (PONV)

    Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours

  • Intensive Care Unit Length of Stay

    From postoperative ICU admission until first ICU discharge, an average of 7 days

  • Ward Length of Stay

    From first ICU discharge until hospital discharge, an average of 14 days

  • +3 more secondary outcomes

Study Arms (2)

SPSIP Block Group

ACTIVE COMPARATOR

Participants in this group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block in addition to standard perioperative care.

Procedure: Serratus posterior superior intercostal plane block

Control Group

ACTIVE COMPARATOR

Participants in this group will receive standard perioperative care without SPSIP block.

Procedure: Standard Perioperative Care

Interventions

After induction of general anesthesia, an ultrasound-guided bilateral serratus posterior superior intercostal plane (SPSIP) block will be performed at the level of the third rib. Under ultrasound guidance, the needle will be advanced to the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After confirmation of appropriate needle-tip position, 20 mL of 0.25% bupivacaine will be administered on each side. The same procedure will then be performed on the contralateral side.

Also known as: SPSIP Block
SPSIP Block Group

Participants in the control group will receive standard perioperative care without serratus posterior superior intercostal plane (SPSIP) block. The perioperative management and postoperative follow-up protocol will otherwise be the same as in the SPSIP block group.

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years
  • Patients scheduled for elective cardiac surgery
  • American Society of Anesthesiologists (ASA) physical status III--IV
  • Patients who provide written informed consent to participate in the study

You may not qualify if:

  • Patient refusal to participate in the study
  • Known allergy to local anesthetics
  • Infection at the site of block application
  • Coagulopathy or contraindication to regional anesthesia
  • Emergency surgery
  • Patients unable to communicate adequately or complete the study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman Training and Research Hospital

Adıyaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

BURAK ÇİLİNGİR, Resident Physician

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Postoperative outcome assessments will be performed by an investigator who is blinded to group allocation. The anesthesiologist performing the SPSIP block will not be involved in postoperative outcome assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the SPSIP block group or the control group. Participants in the SPSIP block group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane block in addition to standard perioperative care, while participants in the control group will receive standard perioperative care without the block.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 25, 2026

Study Start

August 20, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations