Erector Spinae Plane Block in Radical Cystectomy

NCT06422182 | Completed

• 1 other identifier: 2112-301-058
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Erector Spinae Plane Block; Radical Cystectomy

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

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

  48 hours postoperatively

Secondary Outcomes (3)

• The time of first rescue analgesia

  48 hours postoperatively

• Degree of pain

  48 hours postoperatively

• Incidence of side effects

  48 hours postoperatively

Study Arms (2)

Erector Spinae Plane Block group

EXPERIMENTAL

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.

Drug: Bupivacain 25% (Erector Spinae Plane Block)

Intravenous patient-controlled analgesia group

ACTIVE COMPARATOR

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

Drug: Morphine (Intravenous patient-controlled analgesia)

Interventions

Bupivacain 25% (Erector Spinae Plane Block) 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.

Erector Spinae Plane Block group

Morphine (Intravenous patient-controlled analgesia) DRUG

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

Intravenous patient-controlled analgesia group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Interventions

Morphine; Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: July 25, 2021
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)