Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

Pediatric Cancer Clinical Trial

Official title:

Continuous Erector Spinae Plane Local Anesthetic Infusion for Postoperative Analgesia in Pediatric Patients Undergoing Nephrectomy: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613830
• Other study ID #: 515
• Status: Completed
• Phase: Phase 3
• Start date: November 20, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Drug:
• Bupivacaine Hydrochloride
The 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. then injecte bupivacaine hydrochloride
• Tramadol hydrochloride
Patients in group Tramadol will intravenously administrate dose of 1 mg/kg/8hr tramal to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic

Locations

Country	Name	City	State
Egypt	South Egypt Cancer instIitute	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total amount of opioid consumption in milligram	total amount of opioid consumption in the frist 48hours postoperative	48 hours