NCT07330479

Brief Summary

Background: Adequate pain control after video-assisted thoracoscopic surgery (VATS) remains a major clinical challenge. Traditional techniques such as thoracic epidural analgesia are effective but limited by potential complications. Interfascial plane blocks have recently gained interest as safer alternatives. The serratus posterior superior intercostal plane block (SPSIPB) is a novel regional anesthesia technique with potential benefits in thoracic surgery. Objective: The purpose of this study was to evaluate the analgesic efficacy of ultrasound-guided SPSIPB compared with subcutaneous morphine administration in patients undergoing VATS. Methods: In this prospective, randomized controlled trial, 60 patients scheduled for elective VATS were randomized into two groups: SPSIPB group (n=30) and control group receiving subcutaneous morphine (n=30). The primary outcome was postoperative pain intensity measured by the visual analog scale (VAS) at rest and during coughing. Secondary outcomes included opioid consumption, number of patient-controlled analgesia (PCA) demands, rescue analgesia requirements, and incidence of adverse effects.

Trial Health

87
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

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 9, 2025

Last Update Submit

January 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity

    Pain intensity was assessed using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst pain imaginable) at rest and during coughing.

    24 hours after surgery (measured at 0, 2, 4, 8, 16, and 24 hours)

Secondary Outcomes (1)

  • Total opioid consumption within 24 hours

    24 hours after surgery (cumulative from 0 to 24 hours)

Study Arms (2)

SPSIPB Group

EXPERIMENTAL

Patients received an ultrasound-guided SPSIPB with 20 mL local anesthetic at the end of surgery.

Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block

Active Comparator

ACTIVE COMPARATOR

Patients received a subcutaneous morphine injection according to institutional standard practice after surgery.

Drug: Subcutaneous Morphine

Interventions

Intervention Type: Procedure (Regional Anesthesia) Name: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) Description: A single injection of 20 mL of local anesthetic was administered under ultrasound guidance into the serratus posterior superior intercostal plane at the end of surgery.

SPSIPB Group

Intervention Type: Drug (Morphine) Name: Subcutaneous Morphine Description: Patients received a single subcutaneous injection of morphine (dose according to institutional standard practice) after surgery.

Active Comparator

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective video-assisted thoracoscopic surgery (VATS) under general anesthesia
  • Provision of written informed consent

You may not qualify if:

  • Conversion to thoracotomy during surgery
  • Coagulopathy or ongoing anticoagulant therapy
  • Local infection at the injection site
  • Known allergy to local anesthetics or morphine
  • Severe cardiopulmonary disease contraindicating regional anesthesia
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, 27410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Elzem Şen, Assoc. Prof

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 9, 2026

Study Start

February 2, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations