Erector Spinae Plane Block Versus Caudal Epidural Analgesia

Phase 2

Completed

• Conditions: Surgical Pain

• Registration Number: NCT06815094
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

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.

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 Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-28
• Primary Completion: 2023-11-14
• Study Completion: 2024-02-14
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessments of the pain severity intra- and post-operatively.	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.
Recording any complication regarding drugs or procedures.	Intraoperatively and up to 12 hours postoperatively.	for example hypotension or local anaesthetic toxicity.

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, ELkhalig, Egypt