Erector Spinae Plane Block in Radical Cystectomy

Not Applicable

Completed

• Conditions: Erector Spinae Plane Block; Radical Cystectomy
• Interventions: Drug: Bupivacain 25% (Erector Spinae Plane Block); Drug: Morphine (Intravenous patient-controlled analgesia)

• Registration Number: NCT06422182
• Lead Sponsor: Kafrelsheikh University

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.

Study Timeline

• Study Start: 2021-07-25
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-18
• Last Update Submitted: 2024-05-19
• Study First Posted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block group	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.
Intravenous patient-controlled analgesia group	Morphine (Intravenous patient-controlled analgesia)	Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	48 hours postoperatively	Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.

Secondary Outcome Measures

Name	Time	Method
Degree of pain	48 hours postoperatively	Pain assessment will be done at rest and during coughing or movement by numeric rating scale (NRS) from 0 to 10 where 0 means no pain and 10 being worst pain) at PACU, 2, 4, 8, 12, 16 24, 36 and 48 postoperative.
Incidence of side effects	48 hours postoperatively	Side effects such as hypotension, bradycardia, respiratory depression (respiratory rate \<10/minute), urinary retention and postoperative nausea and vomiting (PONV) will be recorded and managed.
The time of first rescue analgesia	48 hours postoperatively	Time from end of surgery to first dose of morphine administrated.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt