Clinical trial NCT06815094: Erector Spinae Plane Block Versus Caudal Epidural Analgesia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Surgical Pain
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized parallel group clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determining the actual postoperative time of need for the first rescue analgesia
timeFrame: Immediately and up to the first 12 hours post-operatively.
measure: Assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery.
timeFrame: Immediately and up to the first 12 hours post-operatively.
Secondary outcomes:
measure: Assessments of the pain severity intra- and post-operatively.
timeFrame: Intraoperatively and up to 12 hours postoperatively.
measure: Recording any complication regarding drugs or procedures.
timeFrame: Intraoperatively and up to 12 hours postoperatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
state: ELkhalig
Study officials:
affiliation: National cancer institute - Cairo university
name: Atef Badran, MD
role: STUDY_DIRECTOR
References: