NCT07655336

Brief Summary

This prospective randomized controlled study aims to compare the effects of Serratus Posterior Superior Intercostal Plane (SPSIP) block and Rhomboid Intercostal and Subserratus (RISS) block on postoperative pain, respiratory function, and recovery quality in patients undergoing volume-preserving video-assisted thoracoscopic surgery (VATS). Eighty-four patients will be randomized in a 1:1 ratio to receive either SPSIP block or RISS block. The primary outcome is the incidence of somatic pain at the chest drain insertion site at postoperative 2 hours. Secondary outcomes include pain scores, opioid consumption, quality of recovery, diaphragmatic function, pulmonary function, rescue analgesic requirements, postoperative nausea and vomiting, and block-related complications.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable postoperative-pain

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%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Video-Assisted Thoracic SurgeryVATSSerratus Posterior Superior Intercostal Plane BlockRhomboid Intercostal and Subserratus BlockDiaphragmatic ExcursionPeak Expiratory Flow

Outcome Measures

Primary Outcomes (1)

  • Incidence of Somatic Pain at Chest Tube Insertion Site

    Incidence of somatic pain localized at the chest tube insertion site, defined as sharp localized pain aggravated by coughing or deep inspiration, recorded as present or absent.

    Postoperative 2 hours

Secondary Outcomes (7)

  • Postoperative Pain Scores at Rest

    Postoperative 2, 6, 12, and 24 hours

  • Postoperative Pain Scores During Movement

    Postoperative 2, 6, 12, and 24 hours

  • Total Intravenous Morphine Consumption

    Postoperative 24 hours

  • Interval Intravenous Morphine Consumption

    Postoperative 0-8, 8-16, and 16-24 hours

  • Right Hemidiaphragm Excursion

    Preoperative and postoperative 6 hours

  • +2 more secondary outcomes

Study Arms (2)

SPSIP Block Group

EXPERIMENTAL

Patients will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for postoperative analgesia after video-assisted thoracic surgery (VATS).

Procedure: Serratus posterior superior intercostal plane block

RISS Block Group

EXPERIMENTAL

Patients will receive an ultrasound-guided Rhomboid Intercostal and Subserratus (RISS) block before induction of general anesthesia for postoperative analgesia after video-assisted thoracic surgery (VATS).

Procedure: Rhomboid Intercostal and Subserratus Block

Interventions

Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed before induction of general anesthesia using local anesthetic for postoperative analgesia in patients undergoing video-assisted thoracic surgery.

SPSIP Block Group

Ultrasound-guided Rhomboid Intercostal and Subserratus (RISS) block performed before induction of general anesthesia using local anesthetic for postoperative analgesia in patients undergoing video-assisted thoracic surgery.

RISS Block Group

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective biportal video-assisted thoracoscopic surgery (VATS) with lung parenchyma-preserving thoracic procedures under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Age between 18 and 75 years
  • Provision of written informed consent

You may not qualify if:

  • Use of anticoagulant or antiplatelet therapy
  • Bleeding diathesis
  • Known allergy to local anesthetics
  • Infection at the planned block site
  • Severe chronic pulmonary disease or advanced respiratory failure (e.g., severe COPD or restrictive lung disease)
  • Cognitive impairment preventing reliable NRS assessment
  • Pregnancy or lactation
  • Chronic opioid use (regular use for ≥3 months)
  • Severe hepatic or renal failure
  • Refusal to participate
  • Technical failure or unsuccessful regional block
  • Conversion to open thoracotomy during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, outcome assessors, and investigators responsible for postoperative data collection and analysis will remain blinded to group allocation throughout the study period. Block procedures will be performed by an anesthesiologist not involved in postoperative assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, double-blind, parallel-group clinical trial comparing Serratus Posterior Superior Intercostal Plane (SPSIP) block and Rhomboid Intercostal and Subserratus (RISS) block for postoperative analgesia after video-assisted thoracic surgery (VATS). Eighty-four participants will be randomized in a 1:1 ratio to receive SPSIP block or RISS block.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations