NCT07412522

Brief Summary

Postoperative pain after cardiac surgery is commonly moderate to severe due to sternotomy, thoracotomy, internal mammary artery harvesting, and chest tube placement, and may contribute to adverse systemic and pulmonary outcomes if inadequately managed. Enhanced Recovery After Surgery (ERAS) protocols emphasize opioid-sparing strategies to reduce opioid-related side effects and complications. Ultrasound-guided fascial plane blocks have increasingly been incorporated into perioperative analgesia protocols for cardiac surgery. The serratus posterior superior intercostal plane block (SPSIPB), a recently described technique, provides wide dermatomal sensory coverage and may offer effective analgesia in thoracic and cardiac surgical procedures. This prospective, randomized controlled study aims to evaluate the analgesic efficacy of SPSIPB in adult patients undergoing off-pump minimally invasive coronary artery bypass grafting (CABG). A total of 60 ASA III patients aged 18 years or older will be randomized into two groups: SPSIPB group and control group. The SPSIPB will be performed preoperatively under ultrasound guidance using 0.25% bupivacaine, while the control group will receive standard general anesthesia without any plane block. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia with tramadol. The primary outcome of the study is postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Secondary outcomes include intraoperative remifentanil consumption, postoperative opioid requirements, time to first rescue analgesia, numerical rating scale (NRS) pain scores at rest and during coughing, extubation time, intensive care unit and hospital length of stay, and postoperative complications such as nausea, vomiting, and atelectasis. This study aims to determine whether SPSIPB can improve postoperative recovery quality and reduce opioid consumption in patients undergoing off-pump minimally invasive CABG.

Trial Health

77
On Track

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
3mo left

Started Sep 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 Progress72%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 4, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Serratus posterior superior intercostal plane blockPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15 (QoR-15) Score

    The Quality of Recovery-15 (QoR-15) questionnaire is a validated patient-reported outcome measure assessing postoperative recovery quality across five domains: pain, physical comfort, physical independence, psychological support, and emotional state. Higher scores indicate better recovery quality.

    24 hours postoperatively

Secondary Outcomes (5)

  • Postoperative Pain Scores (NRS)

    Postoperative 30 minutes, and at 1, 6, 12, 18, and 24 hours

  • Postoperative Total Opioid Consumption

    First 24 hours postoperatively

  • Intraoperative Remifentanil Consumption

    From induction of anesthesia to the end of surgery

  • Time to First Rescue Analgesia

    Within the first 24 hours postoperatively

  • Time to Extubation

    Immediately postoperative period (within the first hours after surgery)

Study Arms (2)

SPSIPB Group

EXPERIMENTAL

Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) prior to induction of general anesthesia. The block will be performed under sterile conditions with the patient in the lateral position using a high-frequency linear ultrasound probe. After identification of the third rib, serratus posterior superior muscle, and pleura, 30 mL of 0.25% bupivacaine (1 mg/kg) will be injected between the serratus posterior superior muscle and the third rib, with confirmation of cranio-caudal spread under ultrasound guidance. All patients will then undergo standardized general anesthesia and postoperative analgesia according to the institutional protocol.

Procedure: Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Drug: BupivacaineDevice: Ultrasound

Control Group

NO INTERVENTION

Participants in this group will receive standardized general anesthesia without any regional or fascial plane block. Intraoperative anesthesia management and postoperative analgesia, including patient-controlled analgesia with tramadol, will be administered according to the same institutional protocol used for the intervention group.

Interventions

Bupivacaine was administered as the local anesthetic for the block.

SPSIPB Group

Ultrasound guidance was used for block placement.

SPSIPB Group

Ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) will be performed prior to induction of general anesthesia under sterile conditions. Patients will be positioned laterally with the surgical side up. Using a high-frequency linear ultrasound probe, the scapular spine and the third rib will be identified medial to the scapula. After confirmation of the serratus posterior superior muscle and pleura, the needle will be advanced until contact with the third rib is achieved. Following hydrodissection with 5 mL of isotonic saline, 30 mL of 0.25% bupivacaine (1 mg/kg) will be injected between the serratus posterior superior muscle and the third rib. Cranio-caudal spread of the local anesthetic will be confirmed under ultrasound guidance. All participants will subsequently receive standardized general anesthesia and postoperative analgesia according to the institutional protocol.

SPSIPB Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75 years
  • ASA physical status II-III
  • Scheduled for elective off-pump minimally invasive coronary artery bypass grafting (CABG) surgery
  • Ability to understand and use the Numerical Rating Scale (NRS)
  • Ability to provide written informed consent

You may not qualify if:

  • Refusal to participate in the study
  • Known allergy or contraindication to local anesthetics
  • Coagulation disorders or ongoing anticoagulant therapy incompatible with regional anesthesia
  • Infection at the block injection site
  • Severe hepatic or renal dysfunction
  • Chronic opioid use or opioid dependence
  • History of chronic pain syndromes
  • Severe pulmonary disease (e.g., advanced COPD)
  • Neurological or psychiatric disorders that may interfere with pain assessment
  • Emergency surgery
  • Conversion to on-pump CABG or sternotomy during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosuyolu High Specialization Training and Research Hospital

Istanbul, 34870, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineUltrasonography

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mustafa Burgaç, himself

    mustafaburgac@outlook.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Burgaç, himself

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group allocation. The anesthesiologist performing the block will not be blinded due to the nature of the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist physician

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 17, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available. However, anonymized data supporting the findings of this study may be shared with qualified researchers upon reasonable request to the corresponding author, in accordance with institutional and ethical regulations.

Locations