Erector Spinae Plane Block in Radical Cystectomy

NCT ID: NCT06422182

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-25
• Study Completion Date: 2024-01-15

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.

Conditions

Erector Spinae Plane Block; Radical Cystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacain 25% (Erector Spinae Plane Block)

Intervention Type: DRUG

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.

Intravenous patient-controlled analgesia group

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

Group Type: ACTIVE_COMPARATOR

Morphine (Intravenous patient-controlled analgesia)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Morphine (Intravenous patient-controlled analgesia)

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Ezzat Abd El Galil

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Countries

Egypt

Other Identifiers

2112-301-058

Identifier Type: -

Identifier Source: org_study_id