Erector Spinae Plane Block Versus Caudal Epidural Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2024-02-14

Brief Summary

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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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Detailed Description

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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.

Conditions

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Surgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized parallel group clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Regional analgesia either CEA or ESP

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Regional analgesia either CEA or ESP

Intervention Type PROCEDURE

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

Interventions

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Regional analgesia either CEA or ESP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No