Rhomboid Intercostal Plane Block vs Local Anesthetic Infilteration for Postoperative Analgesia After Thoracoscopic Surgery

NCT ID: NCT04821947

Last Updated: 2021-03-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-08-01

Brief Summary

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The purpose of the study is to evaluatethe effects of rhomboid intercostal block( RIB ) on postoperative pain after thoracoscopic surgery compared with local anesthetic infiltration ( LA )

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RIB Group

Drug: Bupivacaine 0.25% patients will receive 20 ml of bupivacaine 0.25% in the rhomboid plane under rhomboid major muscle

Group Type ACTIVE_COMPARATOR

Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine

Intervention Type OTHER

for RIB GroupThe following structures will be identified from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between the rhomboid major and intercostal muscles will be identified. A 18 gauge Tuohy needle will be advanced in plane from a superomedial-to-inferolateral direction, through the trapezius and rhomboid major muscles. The skin entry point for the first injection will be the T5-T6 level just medial to the scapula.

After the location is confirmed through hydrodissection of 3 ml on the upper intercostal muscles under the rhomboid major muscle, 20ml of bupivacaine (concentration 0.25%) is injected under rhomboid major muscle LA group will receive wound infiltration of VATS incision single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine

LA Group

Drug: Bupivacaine 0.25% patients will receive wound infiltration of VATS incision, single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine .

Group Type ACTIVE_COMPARATOR

Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine

Intervention Type OTHER

for RIB GroupThe following structures will be identified from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between the rhomboid major and intercostal muscles will be identified. A 18 gauge Tuohy needle will be advanced in plane from a superomedial-to-inferolateral direction, through the trapezius and rhomboid major muscles. The skin entry point for the first injection will be the T5-T6 level just medial to the scapula.

After the location is confirmed through hydrodissection of 3 ml on the upper intercostal muscles under the rhomboid major muscle, 20ml of bupivacaine (concentration 0.25%) is injected under rhomboid major muscle LA group will receive wound infiltration of VATS incision single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine

Interventions

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Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine

for RIB GroupThe following structures will be identified from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between the rhomboid major and intercostal muscles will be identified. A 18 gauge Tuohy needle will be advanced in plane from a superomedial-to-inferolateral direction, through the trapezius and rhomboid major muscles. The skin entry point for the first injection will be the T5-T6 level just medial to the scapula.

After the location is confirmed through hydrodissection of 3 ml on the upper intercostal muscles under the rhomboid major muscle, 20ml of bupivacaine (concentration 0.25%) is injected under rhomboid major muscle LA group will receive wound infiltration of VATS incision single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA status I \&II

Exclusion Criteria

* Allergic constitution
* Severe cardiovascular or hepatorenal insufficiency
* Coagulation system disease
* Injection site infection
* Morbid obesity (BMI\>40 kg/m2).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Heba Fouad, MD

Role: CONTACT

Phone: 01221077317

Email: [email protected]

Rehab Abdelfattah, MD

Role: CONTACT

Phone: 01110108610

Email: [email protected]

Other Identifiers

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FMASU R 34/2021

Identifier Type: -

Identifier Source: org_study_id