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

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

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.

Study Overview

• Status: Completed
• Conditions: Erector Spinae Plane Block; Modified Radical Mastectomy
• Intervention / Treatment: Drug: Erector spinae plane block(15 ml bupivacaine 0.5%); Drug: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Cairo Univesity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Drug: 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).
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed. Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time 1st rescue analgesia	All patients will receive paracetamol 1gm and intravenous ketorolac 30mg will be provided as a part of multimodal analgesia. Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed. Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").	24 hours postoperative
Pain score	Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").it will be assess at 0 , 4, 8, 12, 16, 20 and 24 hours postoperatively.	24 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: MS-520-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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