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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04821947
Other study ID # FMASU R 34/2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date August 1, 2021

Study information

Verified date March 2021
Source Ain Shams University
Contact Heba Fouad, MD
Phone 01221077317
Email heba.toulan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 )


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary Total amount of postoperative analgesic consumption total dose of postoperative tramadol and morphine First 24 hours postoperative
Primary 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
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