Erector Spinae Plane Block in Radical Cystectomy

Kafrelsheikh University

Status: Completed

Conditions: Erector Spinae Plane Block; Radical Cystectomy

Treatments: Drug: Bupivacain 25% (Erector Spinae Plane Block); Drug: Morphine (Intravenous patient-controlled analgesia)

Study type: Interventional

Funder types: Other

Identifiers

NCT06422182

2112-301-058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Erector Spinae Plane Block group

Experimental group

Description:

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.

Treatment:

Drug: Bupivacain 25% (Erector Spinae Plane Block)

Intravenous patient-controlled analgesia group

Active Comparator group

Description:

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

Treatment:

Drug: Morphine (Intravenous patient-controlled analgesia)