NCT07011069

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

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 Progress69%
Nov 2024Dec 2026

Study Start

First participant enrolled

November 15, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

May 23, 2025

Last Update Submit

June 4, 2025

Conditions

Video Assisted Thoracoscopic SurgeryRegional Block for Pain ControlRegional BlocksPulmonary Functions

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Total opioid consumption within the first 24 hours in the postoperative period.

    Postoperative first 24 hours.

Secondary Outcomes (5)

  • Dynamic pain score

    Postoperative first 24 hours.

  • Resting pain score

    Postoperative first 24 hours.

  • Pulmonary functions

    Postoperative first 24 hours.

  • Complications

    Through study completion, an average of 1 year

  • Hospital stay time

    Perioperatively

Study Arms (2)

Patients who received ESP block

ACTIVE COMPARATOR

Those who received the erector spinae plane block for postoperative pain management

Procedure: ESP block group

Patients who received RISS block

ACTIVE COMPARATOR

Those who received the rhomboid intercostal subserratus plane block for postoperative pain management

Procedure: RISS block group

Interventions

ESP block groupPROCEDURE

ESP blocks are performed for patients undergoing VATS.

Patients who received ESP block
RISS block groupPROCEDURE

RISS blocks are performed for patients undergoing VATS.

Patients who received RISS block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Bursa City Hospital

Bursa, Nilufer, 16110, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.

    PMID: 28919152BACKGROUND

  • Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.

    PMID: 30169476BACKGROUND

  • Hsieh MJ, Wang KC, Liu HP, Gonzalez-Rivas D, Wu CY, Liu YH, Wu YC, Chao YK, Wu CF. Management of acute postoperative pain with continuous intercostal nerve block after single port video-assisted thoracoscopic anatomic resection. J Thorac Dis. 2016 Dec;8(12):3563-3571. doi: 10.21037/jtd.2016.12.30.

    PMID: 28149550BACKGROUND

Central Study Contacts

Hande Gurbuz, Assoc Prof, MD, PhD

CONTACT

+905336515650handegrbz@gmail.com

Yusuf Alan, MD

CONTACT

+90 539 621 09 77dryusufalan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof., MD, PhD

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 8, 2025

Study Start

November 15, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
2026 to 2027
Access Criteria
The data sets used in this research may be made available upon reasonable request to the corresponding author.

Locations

TU(1)