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Completed

NCT Number: NCT06422182

Erector Spinae Plane Block in Radical Cystectomy

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.

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Key information

Conditions

Erector Spinae Plane Block Radical Cystectomy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Morphine (Intravenous patient-controlled analgesia)

Drug

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

Primary outcomes

  1. Total morphine consumption

    Time frame: 48 hours postoperatively

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

Secondary outcomes

  1. The time of first rescue analgesia

    Time frame: 48 hours postoperatively

    Time from end of surgery to first dose of morphine administrated.

  2. Degree of pain

    Time frame: 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.

  3. Incidence of side effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 20, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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