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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

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

Conditions
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U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block

Intervention / Treatment
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* Procedure: Serratus Anterior Plane Block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To determine the analgesic effect of ultrasound guided Serratus anterior block combined with modified pectoral nerve block compared to ultrasound guided Serratus Anterior block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Post-operative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 ((Serratus Anterior Plane Block SAPB)<br>N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%. | Procedure: Serratus Anterior Plane Block<br>* 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.<br>* 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)<br>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<br>* 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.<br>* Other names: Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block;|

What is the study measuring?
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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 |