Erector Spinae Plane Block Versus Caudal Epidural Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Pain
• Intervention / Treatment: Procedure: Regional analgesia either CEA or ESP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • ELkhalig
    • Cairo, ELkhalig, Egypt, 11796
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group of patients received Caudal Epidural Analgesia; Pediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute & randomly allocated to this group.	Procedure: Regional analgesia either CEA or ESP; Ultrasound guided local anesthetic injection in the course of the conducting nerve to decrease pain transmission.
Active Comparator: Group of patients received Erector Spinae Plane block; Pediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute & randomly allocated to this group.	Procedure: Regional analgesia either CEA or ESP; Ultrasound guided local anesthetic injection in the course of the conducting nerve to decrease pain transmission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining the actual postoperative time of need for the first rescue analgesia	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.	Immediately and up to the first 12 hours post-operatively.
Assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery.	Calculation of total postoperative morphine consumption in both groups.	Immediately and up to the first 12 hours post-operatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessments of the pain severity intra- and post-operatively.	Using Numerical Rating Score for postoperative pain assessment and vital data with fentanyl consumption for intraoperative pain assessment.	Intraoperatively and up to 12 hours postoperatively.
Recording any complication regarding drugs or procedures.	for example hypotension or local anaesthetic toxicity.	Intraoperatively and up to 12 hours postoperatively.

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Study Director: Atef Badran, MD, National Cancer Institute - Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AP2211-301-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No