Rhomboid Intercostal and Subserratus / Paravertebral Block

NCT ID: NCT06253741

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Analgesia Thoracic Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

PARAVERTEBRAL BLOCK

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

RHOMBOID INTERCOSTAL AND SUBSERRATUS PLANE BLOCK

Intervention Type 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.

PLACEBO

The group without any peripheral block application will be included

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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PVB RISS PG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Seda Cansabuncu

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SEDA CANSABUNCU

Role: PRINCIPAL_INVESTIGATOR

Uludag University

Locations

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Bursa Uludag University

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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SEDA CANSABUNCU

Role: CONTACT

+9002242940000

Other Identifiers

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2022-17/23

Identifier Type: -

Identifier Source: org_study_id

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