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Completed

NCT Number: NCT06815094

Erector Spinae Plane Block Versus Caudal Epidural Analgesia

The goal of this clinical trial is to compare the analgesic effect and safety of erector spinae plane block vs caudal epidural block in paediatric population undergoing lower limb cancer surgery. The main questions it aims to answer are:

* Which of them has a superior analgesic effect. * which of them is more safe and has less complication rate. Participants or their guardians should agree to share in the study (after full explanation of risks and benefits) to receive one of the previously mentioned regional blocks in conjunction with the classic balanced general anaesthesia.

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Key information

Conditions

Surgical Pain

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

National Cancer Institute

Cairo, ELkhalig, 11796, Egypt

About this study

This randomized parallel group clinical trial was carried out on 32 paediatric patients aged from 8 to 15 years old, both sexes, belonging to American Society of Anaesthesiologists II physical status, cancer patient receiving chemotherapy undergoing unilateral lower limb cancer surgery. Patients were divided into two equal groups: Group A: patients received selective unilateral ESPB and group B: patients received CEB. Both in conjunction with general anaesthesia. The primary outcomes were determining the postoperative time of first rescue analgesia and assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery. The secondary outcomes were assessments of the pain severity intra- and post-operative parallel with recording any complication regarding drugs or procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA ( American Society of Anaesthesiologists) II (Cancer patient receiving chemotherapy).
  • 8 - 15 years of age.
  • Planned to undergo unilateral lower limb cancer surgery.

Exclusion criteria

  • Patients with coagulopathy with INR (International Normalization Ratio) > 1.6 (e.g.: haemophilia, fibrinogen abnormalities and deficiency with concentration < 60 %).
  • History of allergy to local anaesthetics or any of the additives.
  • Patients refused to be included in the study or their guardians.
  • CNS (Central Nervous System) pathology.
  • Unstable cardiovascular disease.
  • Local or systemic infection.

Treatment and study plan

Regional analgesia either CEA or ESP

Procedure

Ultrasound guided local anesthetic injection in the course of the conducting nerve to decrease pain transmission.

Primary outcomes

  1. Determining the actual postoperative time of need for the first rescue analgesia

    Time frame: Immediately and up to the first 12 hours post-operatively.

    Compare the actual postoperative time of need for the first rescue analgesia by the Numerical Rating Score in all cases in both groups when it is equal to or more than 4.

  2. Assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery.

    Time frame: Immediately and up to the first 12 hours post-operatively.

    Calculation of total postoperative morphine consumption in both groups.

Secondary outcomes

  1. Assessments of the pain severity intra- and post-operatively.

    Time frame: Intraoperatively and up to 12 hours postoperatively.

    Using Numerical Rating Score for postoperative pain assessment and vital data with fentanyl consumption for intraoperative pain assessment.

  2. Recording any complication regarding drugs or procedures.

    Time frame: Intraoperatively and up to 12 hours postoperatively.

    for example hypotension or local anaesthetic toxicity.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Role of Erector Spinae Plane Block Versus Caudal Epidural Block in Alleviating Intra- & Post-operative Pain in Pediatric Patients Undergoing Lower Limb Cancer Surgeries

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

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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