U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy

U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy,Randomized Double Blinded Comparative Study

We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.

Study Overview

• Status: Completed
• Conditions: U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block
• Intervention / Treatment: Procedure: Serratus Anterior Plane Block

Detailed Description

Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .

The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.

Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients
• Type of surgery; Modified Radical Mastectomy (MRM)
• Physical status ASA I, II, III.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion Criteria:

• Age <18 years or >65 years
• BMI <20 kg/m2 and >35 kg/m2
• Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
• History of psychological disorders and/or chronic pain.
• Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
• Patient refusal.
• Severe respiratory or cardiac disorders.
• Advanced liver or kidney disease.
• Pregnancy.
• Physical status ASA IV and Male patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 ((Serratus Anterior Plane Block SAPB); N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%.	Procedure: Serratus Anterior Plane Block; SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle. SAPB combined with Modified Pectoral Nerve Block : SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle.; Other Names: Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block
Active Comparator: Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block); N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 20 ml levobupivacaine 0.25%and Modified Pectoral Nerve Block with injection of 10 ml levobupivacaine 0.25%between the two pectoralis muscles, after that, the probe was turned toward the axilla, and as the serratus anterior muscle was recognized above the third and fourth ribs, 10 mL of levobupivacaine 0.25% was injected above this muscle	Procedure: Serratus Anterior Plane Block; SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle. SAPB combined with Modified Pectoral Nerve Block : SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle.; Other Names: Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total amount of morphine consumption in the first 24 hours postoperatively	The total amount of morphine consumption in the first 24 hours postoperatively	Through Study Completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of intraoperative fentanyl will be recorded.	Total amount of intraoperative fentanyl will be recorded.	Through Study Completion over the first 24 hrs postoperative
Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.	Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.	Through Study Completion over the first 24 hrs postoperative
The degree of postoperative sedation according to Ramsay scores	postoperative sedation according to Ramsay scores	Through Study Completion over the first 24 hrs postoperative .
Heart rate, mean arterial blood pressure and VAS (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.	Change in hemodynamics ((heart rate and mean arterial blood pressure)	Through Study Completion over the first 24 hrs postoperative
Postoperative nausea and vomiting (PONV) as side effects of morphine.	Nausea and vomiting Scores using a four-point verbal scale:	Through Study Completion over the first 24 hrs postoperative
Time of first rescue analgesia	Time of first rescue analgesia	Through Study Completion over the first 24 hrs postoperative
Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture (US check postoperative).	Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture	Through Study Completion over the first 24 hrs postoperative
Morphine related complications such as respiratory depression, urine retention or pruritis	Morphine related complications such as respiratory depression, urine retention or pruritis	Through Study Completion over the first 24 hrs postoperative
Patient satisfaction the patient will be classified in this group to satisfied or not.	Patient satisfaction the patient will be classified in this group to satisfied or not.	Through Study Completion over the first 24 hrs postoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Samuel Bekhet Moawad; Ahmed Shaker Ragab; Michael Wahib Wadid

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MS-201-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Till publication

Drug and device information, study documents

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