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

NCT06498739 | Completed

• 1 other identifier: MS-520-2022
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Erector Spinae Plane Block; Modified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time 1st rescue analgesia

  24 hours postoperative

• Pain score

  24 hours postoperative

Study Arms (2)

Erector Spinae Plane block (high concentration-low volume)

OTHER

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%)

Erector Spinae Plane block (low concentration-high volume)

OTHER

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)

Interventions

Erector spinae plane block(15 ml bupivacaine 0.5%) 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 (high concentration-low volume)

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

Erector Spinae Plane block (low concentration-high volume)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Women undergoing modified radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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.
• Neurological disorders.
• Patient with psychiatric disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Univesity

Cairo, 11311, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of anesthesiology and surgical ICU and pain management

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: July 12, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)