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

NCT05006612 | Completed DMC

• 1 other identifier: MS-201-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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.

  Through Study Completion over the first 24 hrs postoperative

• The degree of 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.

  Through Study Completion over the first 24 hrs postoperative

• Postoperative nausea and vomiting (PONV) as side effects of morphine.

  Through Study Completion over the first 24 hrs postoperative

Study Arms (2)

Group 1 ((Serratus Anterior Plane Block SAPB)

ACTIVE COMPARATOR

N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%.

Procedure: Serratus Anterior Plane Block

Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block)

ACTIVE COMPARATOR

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

Interventions

Serratus Anterior Plane Block PROCEDURE

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.

Also known as: Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block

Group 1 ((Serratus Anterior Plane Block SAPB); Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Samuel Bekhet Moawad: collaborator
• Ahmed Shaker Ragab: collaborator
• Michael Wahib Wadid: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 16, 2021
• Study Start: June 14, 2021
• Primary Completion: August 16, 2021
• Study Completion: August 23, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

EG (1)