Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy

Cairo University (CU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM

Treatments: Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block); Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)

Study type: Interventional

Funder types: Other

Identifiers

NCT05813158

N-44-2022/MSc

Details and patient eligibility

About

The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM.

Full description

Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery including ESPB aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block)..

Ultrasound guided erector spinae plane (ESPB) block was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, performing the ESPB has relatively few contraindications. The injected local anesthetic drug blocks the ventral and dorsal rami of spinal nerves on the paravertebral area .

Multiple studies have reported improved efficiency of interfascial blocks by increasing the volume of injection promoting better spread of local anesthesia. According to the authors best knowledge there is no studies comparing different volumes and concentration in ESPB in patients undergoing MRM This study aims to see the effect of fixing the drug mass of anaesthetic given in both groups, while altering the concentration of the anesthetic and total volume administered. One group will receive a lower concentration and higher volume, while the other will receive a higher concentration and lower volume.

Enrollment: 52 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Age starting from 18 to 60 years.

• Genders eligible for study: female sex.
• ASA II-III.
• Patients undergoing modified radical mastectomy.
• Body mass index (BMI) from 18.5 to 30 kg/m2.

Exclusion criteria

Patient refusal

• Known allergy to local anesthetics
• Bleeding disorders; platelets count <50,000, prothrombin concentration <60% or any coagulopathy disorder.
• Use of any anti-coagulants
• Inability to provide informed consent
• ASA IV
• Neurological disorders
• Patient with psychiatric disorders

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Patients will preoperatively receive low concentration-high volume U/S ESP block, and then the patient will be transferred to the operating room one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient.

Treatment:

Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)

Group 2

Active Comparator group

Description:

Patients will preoperatively receive high concentration-low volume U/S ESP block block, and then the patient will be transferred to the operating room one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patien).

Treatment:

Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)