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

Effects of Rhomboid Intercostal Plane Block for Postoperative Analgesia After Thoracoscopic Surgery Compared With Local Anesthetic Infilteration: A Randomized Clinical Trial

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 )

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Other: Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Fouad, MD; Phone Number: 002 01221077317; Email: heba.toulan@gmail.com
• Study Contact Backup: Name: Rehab Abdelfattah, MD; Phone Number: 002 01110108610; Email: rehab.fattah2002@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIB Group; Drug: Bupivacaine 0.25% patients will receive 20 ml of bupivacaine 0.25% in the rhomboid plane under rhomboid major muscle	Other: 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
Active Comparator: 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 .	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of postoperative analgesic consumption	total dose of postoperative tramadol and morphine	First 24 hours postoperative
Visual Analogue Score ( VAS )	VAS will be measured at 1st, 2nd, 4th, 6th, 12th, 24th hours postoperative at rest and during cough	First 24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: FMASU R 34/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No