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

NCT04821947 | Unknown

• 1 other identifier: FMASU R 34/2021
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 )

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

RIB Group

ACTIVE COMPARATOR

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

LA Group

ACTIVE COMPARATOR

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

Interventions

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

Eligibility Criteria

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

You may qualify if:

• ASA status I \&II

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Heba Fouad, MD

CONTACT

01221077317; heba.toulan@gmail.com

Rehab Abdelfattah, MD

CONTACT

01110108610; rehab.fattah2002@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: April 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03