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Clinical Trials/NCT06422182
NCT06422182
Completed
Not Applicable

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

Kafrelsheikh University1 site in 1 country60 target enrollmentJuly 25, 2021

Overview

Phase
Not Applicable
Intervention
Bupivacain 25% (Erector Spinae Plane Block)
Conditions
Erector Spinae Plane Block
Sponsor
Kafrelsheikh University
Enrollment
60
Locations
1
Primary Endpoint
Total morphine consumption
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life. Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses. One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.

Registry
clinicaltrials.gov
Start Date
July 25, 2021
End Date
January 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tarek Ezzat Abd El Galil

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt

Kafrelsheikh University

Eligibility Criteria

Inclusion Criteria

  • Age of the patient between 21 to 65 years.
  • Both sexes.
  • Body mass index (BMI): 20 - 40 kg/m
  • 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.

Arms & Interventions

Erector Spinae Plane Block group

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.

Intervention: Bupivacain 25% (Erector Spinae Plane Block)

Intravenous patient-controlled analgesia group

Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine

Intervention: Morphine (Intravenous patient-controlled analgesia)

Outcomes

Primary Outcomes

Total morphine consumption

Time Frame: 48 hours postoperatively

Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.

Secondary Outcomes

  • Degree of pain(48 hours postoperatively)
  • Incidence of side effects(48 hours postoperatively)
  • The time of first rescue analgesia(48 hours postoperatively)

Study Sites (1)

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