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Clinical trial

Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study

ID
Name
2112-301-058
Description
The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.
Trial arms
Trial start
2021-07-25
Estimated PCD
2024-01-15
Trial end
2024-01-15
Status
Completed
Treatment
Bupivacain 25% (Erector Spinae Plane Block)
Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery.
Arms:
Erector Spinae Plane Block group
Morphine (Intravenous patient-controlled analgesia)
Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine
Arms:
Intravenous patient-controlled analgesia group
Size
60
Primary endpoint
Total morphine consumption
48 hours postoperatively
Eligibility criteria
Inclusion Criteria: * Age of the patient between 21 to 65 years. * Both sexes. * Body mass index (BMI): 20 - 40 kg/m2. * American Society of Anesthesiologists (ASA) physical status II-III. * Elective radical cystectomy. Exclusion Criteria: * Patient refusal. * Psychiatric and cognitive disorders. * Local infection at the site of injection. * Allergy to study medications. * Anatomic abnormalities. * Inability to comprehend or participate in pain scoring system.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-05-21

1 organization

2 products

2 indications

Organization
Kafrelsheikh University
Product
Bupivacain
Indication
Erector Spinae Plane Block
Indication
Radical Cystectomy
Product
Morphine