Erector Spinae Plane Block in Radical Cystectomy

Erector Spinae Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06422182
• Other study ID #: 2112-301-058
• Status: Completed
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: January 15, 2024

Study information

• Verified date: May 2024
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Radical Cystectomy

Intervention

Drug:
• 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.
• Morphine (Intravenous patient-controlled analgesia)
Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The time of first rescue analgesia	Time from end of surgery to first dose of morphine administrated.	48 hours postoperatively
Secondary	Degree of pain	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.	48 hours postoperatively
Secondary	Incidence of side effects	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.	48 hours postoperatively