Rhomboid Intercostal and Subserratus / Paravertebral Block

NCT06253741 | Not Yet Recruiting

• 1 other identifier: 2022-17/23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia; Thoracic; Anesthesia

Outcome Measures

Primary Outcomes (1)

• VAS scores

  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 Outcomes (3)

• morphine consumption

  up to 24 hours

• first analgesia requirement

  up to 24 hours

• Side effects

  up to 24 hours

Study Arms (3)

PARAVERTEBRAL BLOCK

ACTIVE COMPARATOR

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

RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK

ACTIVE COMPARATOR

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

PLACEBO

PLACEBO COMPARATOR

The group without any peripheral block application will be included

Procedure: PLACEBO

Interventions

PARAVERTEBRAL BLOCK PROCEDURE

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

Also known as: PVB

PARAVERTEBRAL BLOCK

RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK PROCEDURE

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.

Also known as: RISS

RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK

PLACEBO PROCEDURE

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.

Also known as: PG

PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SEDA CANSABUNCU

  Uludag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEDA CANSABUNCU

CONTACT

+9002242940000; sedacansabuncu@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)