NCT07553208

Brief Summary

This prospective interventional study aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) block and the Erector Spinae Plane (ESP) block in patients undergoing surgical stabilization of rib fractures. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and quality of recovery assessed using the QoR-15 questionnaire.

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

Timeline
19mo left

Started Nov 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

First Submitted

Initial submission to the registry

April 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

November 15, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 21, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

serratus posterior superior intercostal plane blockspsıp blockerector spine plane blockesprib fixationregioanl anethesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity assessed using the Visual Analog Scale (VAS)

    Postoperative pain intensity (VAS score) Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Measurements will be recorded at predefined time points within the first 24 hours after surgery.

    0, 1, 4, 8, 12, and 24 hours after surgery

Secondary Outcomes (7)

  • Total opioid consumption via patient-controlled analgesia (PCA)

    Within the first 24 hours postoperatively

  • Requirement for rescue analgesia

    Within the first 24 hours postoperatively

  • Block performance time

    During the block procedure (intraoperative period)

  • Block-related and systemic side effects

    Within the first 24 hours postoperatively

  • Patient and Surgeon satisfaction assessed using a Likert scale

    At 24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Serratus Posterior Superior Intercostal Plane Block (SPSIP)

ACTIVE COMPARATOR

Serratus Posterior Superior Intercostal Plane

Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP)

Erector Spinae Plane Block (ESP)

ACTIVE COMPARATOR

Erector Spinae Plane Block

Procedure: Erector Spinae Plane Block (ESP)

Interventions

Patients in this group will receive an ultrasound-guided Erector Spinae Plane Block (ESP) with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the erector spinae muscle and the fifth vertebral transverse processes, 30 minutes before surgery.

Erector Spinae Plane Block (ESP)

Patients in this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus posterior superior muscle and the third rib, 30 minutes before surgery.

Serratus Posterior Superior Intercostal Plane Block (SPSIP)

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective video-assisted thoracoscopic surgery
  • Body mass index (BMI) between 18 and 35 kg/m²
  • Ability to understand and use the patient-controlled analgesia (PCA) device
  • Ability to provide written informed consent

You may not qualify if:

  • Refusal to participate
  • Allergy to local anesthetics
  • Infection at the injection site
  • Coagulopathy or ongoing anticoagulant therapy
  • Chronic opioid use or opioid dependence
  • Severe hepatic or renal insufficiency
  • Pregnancy or breastfeeding
  • Cognitive impairment or inability to communicate pain scores
  • Body mass index (BMI) \<18 or \>35 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya City Hospitial, Ministry of Health, Turkey

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rib FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • MUSTAFA KILIN

    ANTALYA CİTY HOSPİTAL, MİNİSTRY OF HEALTH, TURKEY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa KILIN, Consultant Anesthesiologist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiologist

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 27, 2026

Study Start (Estimated)

November 15, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations