Clinical trial
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
Name
N-44-2022/MSc
Description
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.
Trial arms
Trial start
2022-09-09
Estimated PCD
2022-12-16
Trial end
2022-12-23
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Group 1
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)
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).
Arms:
Group 2
Other names:
Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%
Size
52
Primary endpoint
Total dose of morphine needed postoperatively
Through Study Completion Up to 1 Day
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients will be randomly allocated to one of the two groups by sealed closed envelop technique', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}
Updated at
2023-05-03
1 organization
2 products
1 indication
Organization
Cairo UniversityProduct
Group 1