Comparing the 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

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.

Study Overview

• Status: Completed
• Conditions: Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM
• Intervention / Treatment: 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)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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.	Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block); Patients will preoperatively receive low concentration-high volume ultasound 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; Other Names: Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%
Active Comparator: Group 2; 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).	Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block); Patients will preoperatively receive high concentration-low volume ultasound 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 patien).; Other Names: Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of morphine needed postoperatively	Total dose of morphine needed postoperatively	Through Study Completion Up to 1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss,	Blood loss,	Through Study Completion,an average of 1day
Total dose of fentanyl required intraoperative (including induction dose)	Total dose of fentanyl required intraoperative (including induction dose)	Through study completion,an average of 1day
Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery	Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery	through study completion,an average of 1day
Time to first rescue analgesia, starting after extubation	Time to first rescue analgesia, starting after extubation	Through Study Completion over the first 24 hours postoperative
Duration of surgery	Duration of surgery	Through Study Completion 24 hours postoperative
Need for blood transfusion	Need for blood transfusion	Through Study Completion over the first 24 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Norhan Abdelaleem Ali; Ahmed Shaker Ragab; Yasmina sayed Abdrabo Ismael

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: N-44-2022/MSc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Till Study Ending

Drug and device information, study documents

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