Completed

NCT Number: NCT05813158

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

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.

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Key information

Conditions

Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%

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).

Other names: Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%

Primary outcomes

Total dose of morphine needed postoperatively

Time frame: Through Study Completion Up to 1 Day

Total dose of morphine needed postoperatively

Secondary outcomes

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
Duration of surgery

Time frame: Through Study Completion 24 hours postoperative

Duration of surgery
Blood loss,

Time frame: Through Study Completion,an average of 1day

Blood loss,
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)
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
Need for blood transfusion

Time frame: Through Study Completion over the first 24 hours postoperative

Need for blood transfusion

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

Ahmed Shaker Ragab
Norhan Abdelaleem Ali
Yasmina sayed Abdrabo Ismael

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 14, 2023
Registry last updated: May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.