Erector Spinae Plane Block Versus Caudal Epidural Analgesia

National Cancer Institute, Egypt

Status and phase: Completed; Phase 3; Phase 2

Conditions: Surgical Pain

Treatments: Procedure: Regional analgesia either CEA or ESP

Study type: Interventional

Funder types: Other

Identifiers

NCT06815094

AP2211-301-044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Group of patients received Caudal Epidural Analgesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Regional analgesia either CEA or ESP

Group of patients received Erector Spinae Plane block

Active Comparator group

Description:

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.

Treatment:

Procedure: Regional analgesia either CEA or ESP