Rhomboid Intercostal and Subserratus / Paravertebral Block

February 9, 2024 updated by: Seda Cansabuncu, Uludag University

"Comparison of Rhomboid Intercostal and Subserratus Plane Blocks Applied for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery With Thoracic Paravertebral Block"

Postoperative pain is a significant concern following video-assisted thoracoscopic surgery (VATS). Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. Hence, different analgesia techniques, including local anesthetic infiltration, intercostal nerve block, paravertebral block, and thoracic epidural anesthesia, have been described to attenuate the intensity of acute postoperative painparavertebral block (PVB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultra- sound-guided PVB and RISS block after video-assisted thoracoscopic surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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

Study Locations

  • Turkey
      • Bursa, Turkey
        • Bursa Uludağ University

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:

  • Planned for VATS
  • American Society of Anesthesiologists (ASA) class I and II
  • Patients aged between 18-80

Exclusion Criteria:

  • Contraindications to local anesthetic allergy or bupivacaine
  • Known or suspected coagulopathy
  • Injection site infection
  • History of thoracic surgery
  • Severe neurological or psychiatric disorder
  • Severe cardiovascular disease
  • Liver failure
  • Renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
  • Chronic opioid use

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PARAVERTEBRAL BLOCK
After induction of general anesthesia and endotracheal intubation in the operating room, following the positioning of the patient for surgery, ultrasound-guided paravertebral block (PVB) will be routinely performed in our clinic using 0.25% bupivacaine solution at a dose of 0.5 ml/kg.
Procedure: PARAVERTEBRAL BLOCK
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes
Other Names:
  • PVB
Active Comparator: RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK
After induction of general anesthesia and endotracheal intubation in the operating room, following the positioning of the patient for surgery, rhomboid intercostal block with sub-serratus plane block (RISS) will be routinely performed in our clinic using 0.25% bupivacaine solution at a dose of 0.5 ml/kg under ultrasound guidance.
Procedure: RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes.
Other Names:
  • RISS
Placebo Comparator: PLACEBO
The group without any peripheral block application will be included
Procedure: PLACEBO
Hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded for all patients every 30 minutes during the intraoperative period, along with the amount of opioids used throughout the surgery. A patient-controlled analgesia device (PCA) will be connected to each patient 15 minutes before awakening, prepared with a 1mg/ml morphine solution, with a bolus dose of 2 ml and a lockout period of 15 minutes.
Other Names:
  • PG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS scores
Time Frame: up to 24 hours
The primary outcome of this study was to compare the analgesia of paravertebral block versus rhomboid intercostal and subserratus plane block in VATS surgery.
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: up to 24 hours
The secondary outcome measure in this study was 24-hour morphine consumption.
up to 24 hours
first analgesia requirement
Time Frame: up to 24 hours
Secondary outcome measures included time to first request for morphine
up to 24 hours
Side effects
Time Frame: up to 24 hours
Side effects associated with morphine consumption
up to 24 hours

Collaborators and Investigators

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

Sponsor

Uludag University

Investigators

  • Principal Investigator: SEDA CANSABUNCU, Uludag University

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-17/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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