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

April 28, 2023 updated by: Ahmed Abdalla, Cairo University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Through Study Completion Up to 1 Day
Total dose of morphine needed postoperatively
Through Study Completion Up to 1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss,
Time Frame: Through Study Completion,an average of 1day
Blood loss,
Through Study Completion,an average of 1day
Total dose of fentanyl required intraoperative (including induction dose)
Time Frame: Through study completion,an average of 1day
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
Time Frame: through study completion,an average of 1day
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 Frame: Through Study Completion over the first 24 hours postoperative
Time to first rescue analgesia, starting after extubation
Through Study Completion over the first 24 hours postoperative
Duration of surgery
Time Frame: Through Study Completion 24 hours postoperative
Duration of surgery
Through Study Completion 24 hours postoperative
Need for blood transfusion
Time Frame: Through Study Completion over the first 24 hours postoperative
Need for blood transfusion
Through Study Completion over the first 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Norhan Abdelaleem Ali
Ahmed Shaker Ragab
Yasmina sayed Abdrabo Ismael

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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