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Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

Sponsor
Assiut University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04613830
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
25.3
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine Hydrochloride
  • Drug: Tramadol hydrochloride
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Continuous Erector Spinae Plane Local Anesthetic Infusion for Postoperative Analgesia in Pediatric Patients Undergoing Nephrectomy: Randomized Controlled Study
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Nov 12, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Erector spinae group

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 T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.

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 T7 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
Other Names:
  • erector spinae block

    		•
    Placebo Comparator: Opioid GROUP

    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.

    Drug: 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
    Other Names:
  • opioid group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. total amount of opioid consumption in milligram [48 hours]

      total amount of opioid consumption in the frist 48hours postoperative

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Egypt Cancer instIitute Assuit Egypt 171516

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: fatma el sherif, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatma Adel El sherif,MD, Associated professor of anesthesia,ICU and pain management, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04613830
    Other Study ID Numbers:
    • 515
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Tramadol
    Bupivacaine

    Study Results

    No Results Posted as of Aug 12, 2022