Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

Phase 3

Completed

• Conditions: Pediatric Cancer
• Interventions: Drug: Tramadol hydrochloride; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04613830
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study is to evaluate the analgesic efficacy of erector spinae plane block in pediatric cancer patients undergoing open nephrectomy

Detailed Description

* Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30).

* All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block

Study Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2020-11-20
• Primary Completion: 2022-11-12
• Study Completion: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Physical status ASA II.
• Patients (age 2-7yrs) scheduled for open nephrectomy for malignant kidney tumors

Exclusion Criteria

• History of psychological disorders.

  • Known sensitivity or contraindication to local anesthetics.
  • Localized infection at the site of block.
  • patients with coagulopathy or an (INR ≥ 2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid GROUP	Tramadol hydrochloride	Patient in group T will intravenously administrate dose of 1 mg/kg/8hr tramal ( opioid) to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic.
Erector spinae group	Bupivacaine Hydrochloride	patient will be placed in a sitting position under complete aseptic condition and a cover sheath will be used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the L3 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.

Primary Outcome Measures

Name	Time	Method
total amount of opioid consumption in milligram	48 hours	total amount of opioid consumption in the frist 48hours postoperative

Trial Locations

Locations (1)

South Egypt Cancer instIitute; 🇪🇬 Assuit, Egypt