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

NCT ID: NCT06498739

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-09-01

Brief Summary

Comparing the perioperative analgesic effect of two different volumes of local anesthetic solution in erector spinae plane block in patients undergoing modified radical mastectomy. A randomized comparative study.

Detailed Description

Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.

Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (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 block (ESPB) 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.

Conditions

Erector Spinae Plane Block; Modified Radical Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Erector Spinae Plane block (high concentration-low volume)

Patients will preoperatively receive high concentration-low volume ultrasound guided Erector Spinae Plane 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 patient).

Group Type: OTHER

Erector spinae plane block(15 ml bupivacaine 0.5%)

Intervention Type: DRUG

Patients will preoperatively receive high concentration-low volume ultrasound guided Erector Spinae Plane 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 patient).

Erector Spinae Plane block (low concentration-high volume)

Patients will preoperatively receive low concentration-high volume ultrasound guided Erector Spinae Plane 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.

Group Type: OTHER

Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)

Intervention Type: DRUG

Patients will preoperatively receive low concentration-high volume ultrasound guided Erector Spinae Plane 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.

Interventions

Erector spinae plane block(15 ml bupivacaine 0.5%)

Patients will preoperatively receive high concentration-low volume ultrasound guided Erector Spinae Plane 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 patient).

Intervention Type: DRUG

Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)

Patients will preoperatively receive low concentration-high volume ultrasound guided Erector Spinae Plane 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 60 years.
• Genders eligible for study: female sex.
• American Society of Anesthesiologists (ASA) I-II.
• Undergoing modified radical mastectomy.
• Body mass index (BMI) from 18.5 to 30 kg.

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.
• Neurological disorders.
• Patient with psychiatric disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmina Sayed

Assistant lecturer of anesthesiology and surgical ICU and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo Univesity

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-520-2022

Identifier Type: -

Identifier Source: org_study_id