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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06187909
Other study ID # FMASU MD311/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date January 10, 2025

Study information

Verified date November 2023
Source Ain Shams University
Contact Diaa eldin M. haiba, phD
Phone 01006516286
Email beethoven_1993@windowslive.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the midpoint transverse process to pleura block (MTP), after modified radical mastectomy (MRM) surgery during the first 24 hour post-operatively by using the Visual Analogue Scale.


Description:

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Study Design


Intervention

Procedure:
PECS II BLOCK
The linear probe will be placed transversely between the clavicle medially and above . After identifying the pectoralis major and minor muscles , the probe will be angled caudally to look for the pulsating pectoral branch of the thoraco-acromial artery. The block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered. Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The third and fourth ribs will be detected. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 20 ml bupivacaine.
MTP BLOCK
The block will be performed with the patient in a sitting position ,High frequency linear probe will be placed in a vertical orientation 3 cm lateral to the midline at T2 level in parasagittal plane. We will identify the midpoint between the transverse process and parietal pleura, and the distance from this point to the skin will be measured which will be the measured depth of insertion and will be marked in the block needle. The block needle will be inserted out of plane to the probe and advanced till the marked depth till the point is confirmed, 10 ml of 0.25% bupivacaine will be injected. Similar two injections will be made at T4, T6 levels sonographic identification and level determination by counting from the second rib.

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative pain severity assessed by VAS at zero time (on admission to the PACU) Comparison between postoperative pain severity on arrival to post anesthesia care unit between both groups using visual analogue score will be evaluated post-operatively at zero time
Secondary Post-operative pain severity assessed by VAS at 2 hr, 4 hr, 8hr, 16 hr and 24 hr Comparison between postoperative pain severity after 2 hours, 4 hours, 8 hours,16 hours and 24 hours postoperative between both groups using visual analogue score 24 hours postoperatively
Secondary Time of first rescue analgesia Comparison between both groups regarding the time of first needed dose of meperidine 24 hours postoperatively
Secondary Cumulative post-operative meperidine consumption in the first 24 hours Comparison between both groups regarding total consumed meperidine in first 24 hours postoperative 24 hours postoperatively
Secondary Block failure rate Comparison between both groups regarding failure rate 24 hours postoperatively
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