US-Guided PECS II Block Versus MTP Block For Postoperative Analgesia Of MRM Sugery

Analgesia Clinical Trial

Official title:

Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Midpoint Transverse Process To Pleura (MTP) Block For Postoperative Analgesia Of Modified Radical Mastectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187909
• Other study ID #: FMASU MD311/2023
• Status: Recruiting
• Phase: N/A
• 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
• 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:

During Modified radical mastectomy (MRM), some of the nerves in the chest are severed. Most women have some level of pain in the days after the procedure. Severe acute postoperative pain following breast surgery not only increases the risk of persistent pain and affects recovery, it also leads to longer hospitalization and increased healthcare costs. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain. PECS-II is an interfascial plane block in which local anesthetic is injected between the pectoralis and serratus anterior muscles that blocks the long thoracic nerve as well as the pectoral, intercostobrachial, and inter-costal III, IV, V, and VI nerves. PECS-II is a less invasive and easier to perform alternative to thoracic paravertebral block (TPVB). This block, defined by Blanco et al., provides adequate and safe post-operative analgesia in the anterior chest wall after breast surgery. The most common complications are pneumothorax, infection, local anesthetic systemic toxicity (LAST)/allergy, vascular puncture, and failed block. The MTP block was first described as a modified paravertebral block in 2017. The local anesthetic (LA) is administered between the transverse process and the pleura. This results in a LA spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotransverse ligament (SCTL) at the level of injection, and frequently to adjacent levels. The advantage of this novel technique is that it does not require identification of the SCTL and the injection point, which is midway between the pleura and transverse process, which makes this approach much safer than the conventional TPVB approach since the needle is farther from the vital structures like pleura, nerves, and vasculature. This technique is used for pain relief after mastectomy, thoracic, abdominal, and spinal surgery and was found effective due to its simplicity and lower risks compared to epidural analgesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: January 10, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Female patients scheduled for MRM.

2. Age eligible = 40 & = 65 yrs.

3. Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for MRM surgery.

Exclusion Criteria:

1. Age < 40 & > 65 years old.

2. Declining to give written informed consent.

3. History of allergy to the medications used in the study.

4. Contraindication to regional anesthesia (including coagulopathy (platelet count = 80,000, INR = 1.5) and local infection).

5. Severe hepatic impairment (INR = 1.5, Bilirubin = 2, Albumin = 2).

6. Renal dysfunction [Glomerular filtration rate < 50ml/min calculated by Modification of diet in renal disease equation for GFR estimation].

7. Psychiatric disorder.

8. Pregnancy.

9. Patient with history of thoracic spine surgery.

Related Conditions & MeSH terms

• Analgesia
• Anesthesia, Local
• Neuromuscular Blockade
• Pain, Postoperative
• Post Operative Pain

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