Rhomboid Intercostal and Subserratus Plane Block vs Erector Spinae Plane Block in Video-Assisted Thoracoscopic Surgery

June 4, 2025 updated by: Hande Gurbuz, Bursa City Hospital

Comparison of the Efficacy of Rhomboid Intercostal and Subserratus Plane Block (RISS) Versus Erector Spinae Plane (ESP) Blocks in Video-Assisted Thoracoscopic Surgery (VATS) for Postoperative Pain Management and Respiratory Function

To compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Video-assisted thoracoscopic surgery (VATS) can be very painful and may lead to complications such as prolonged stays in intensive care, thromboembolic complications due to lack of early mobilization, chronic acute pain, and delirium if adequate analgesia is not provided. Therefore, using thoracic epidural, paravertebral, or regional blocks as part of multimodal analgesia is recommended to provide effective pain relief.

This study aims to compare the effects of the erector spinae plane block (ESP) and rhomboid intercostal subserratus plane block (RISS) on postoperative analgesia and the improvement of respiratory parameters in patients undergoing VATS.

The primary objective is to evaluate total analgesic consumption in the first 24 hours postoperatively. Secondary objectives include assessing active and dynamic pain scores, triflow performance, complications, and the length of hospital stays.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hande Gurbuz, Assoc Prof, MD, PhD
  • Phone Number: +905336515650
  • Email: handegrbz@gmail.com

Study Contact Backup

Study Locations

  • Turkey
    • Nilufer
      • Bursa, Nilufer, Turkey, 16110
        • Recruiting
        • University of Health Sciences, Bursa City Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hande Gurbuz, Assoc Prof, MD, PhD
        • Sub-Investigator:
          • Yusuf Alan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who will undergo VATS
  • Who agrees to participate
  • American Society of Anesthesiologists (ASA) physical status I, II, and III
  • Elective surgery
  • Age between 18 and 80 years

Exclusion Criteria:

  • Local anesthetic allergy
  • Who disagrees to participate
  • ASA physical status IV and V
  • Emergency surgery
  • Hemorrhagic disease
  • Thoracic vertebrae deformity
  • Thoracic vertebrae surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients who received ESP block
Those who received the erector spinae plane block for postoperative pain management
Procedure: ESP block group
ESP blocks are performed for patients undergoing VATS.
Active Comparator: Patients who received RISS block
Those who received the rhomboid intercostal subserratus plane block for postoperative pain management
Procedure: RISS block group
RISS blocks are performed for patients undergoing VATS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: Postoperative first 24 hours.
Total opioid consumption within the first 24 hours in the postoperative period.
Postoperative first 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic pain score
Time Frame: Postoperative first 24 hours.
Postoperative pain scores during coughing and deep breathing are measured on a 10 cm scale, where "0" indicates no pain and "10" indicates the worst pain ever.
Postoperative first 24 hours.
Resting pain score
Time Frame: Postoperative first 24 hours.
Postoperative pain scores during rest are measured on a 10 cm scale, where "0" indicates no pain and "10" indicates the worst pain ever.
Postoperative first 24 hours.
Pulmonary functions
Time Frame: Postoperative first 24 hours.
Pulmonary functions are assessed using Triflow performance. Postoperative Triflow numbers (whether 1, 2, or 3 balls can be raised) for the patients are recorded.
Postoperative first 24 hours.
Complications
Time Frame: Through study completion, an average of 1 year
Complications regarding regional blocks and surgery (such as hematoma, pulmonary complications) are recorded.
Through study completion, an average of 1 year
Hospital stay time
Time Frame: Perioperatively
The length of hospital stay is recorded.
Perioperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 23, 2025

First Submitted That Met QC Criteria

June 4, 2025

First Posted (Actual)

June 8, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-11/4 24-AKD-209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets used in this research may be made available upon reasonable request to the corresponding author.

IPD Sharing Time Frame

2026 to 2027

IPD Sharing Access Criteria

The data sets used in this research may be made available upon reasonable request to the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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