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

NCT05813158 | Completed Phase 2 DMC

• 1 other identifier: N-44-2022/MSc
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM

Outcome Measures

Primary Outcomes (1)

• Total dose of morphine needed postoperatively

  Total dose of morphine needed postoperatively

  Through Study Completion Up to 1 Day

Secondary Outcomes (6)

• Time to first rescue analgesia, starting after extubation

  Through Study Completion over the first 24 hours postoperative

• Duration of surgery

  Through Study Completion 24 hours postoperative

• Blood loss,

  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

  through study completion,an average of 1day

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Group 2

ACTIVE COMPARATOR

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)

Interventions

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

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

Also known as: Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%

Group 1

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

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).

Also known as: Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Yasmina sayed Abdrabo Ismael: collaborator
• Norhan Abdelaleem Ali: collaborator
• Ahmed Shaker Ragab: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Officials

• Ahmed Abdalla Mohamed, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be randomly allocated to one of the two groups by sealed closed envelop technique
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: We hypothesize that high volume low concentration ultrasound-guided Erector Spinae Plane block is going to be more effective than low volume high concentration in patients undergoing MRM. Many authors advocate increasing the volume of injection in fascial plane blocks to allow better spread of local anesthetic according to multiple studies

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: April 14, 2023
• Study Start: September 9, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 23, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

EG (1)