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Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT04518215
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Nazmy Edward Seif, Cairo University

Study Description
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Brief Summary:
Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.

Condition or disease Intervention/treatment Phase
Paediatric Surgery Analgesia Anesthesia Procedure: Erector Spinae Plain Block Procedure: Intra-Venous Analgesia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ESPB group
Erector Spinae Plain Block
 Procedure: Erector Spinae Plain Block
Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.

Procedure: Intra-Venous Analgesia
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.
Active Comparator: IV Analgesia group
Intra-Venous Analgesia
 Procedure: Intra-Venous Analgesia
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.


Outcome Measures
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Primary Outcome Measures :
  1. Tramadol consumption. [ Time Frame: 24 hours ]
    Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I - II.
  • Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.

Exclusion Criteria:

  • Patient's next of kin refusal.
  • Allergy to local anaesthetics.
  • Infection at the site of injection.
  • Coagulopathy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518215


Contacts
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Contact: Atef K Salama, MD 01001155851 ext +2 atef.kamel@kasralainy.edu.eg
Contact: Nazmy S Michael, MD 01227400808 ext +2 nazmy.seif@gmail.com

Locations
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Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: Atef K Salama, MD    01001155851 ext +2    atef.kamel@kasralainy.edu.eg   
Contact: Nazmy S Michael, MD    01227400808 ext +2    nazmy.seif@gmail.com   
Sponsors and Collaborators
Nazmy Edward Seif
Investigators
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Principal Investigator: Atef K Salama, MD Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Study Director: Nazmy S Michael, MD Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
More Information
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Responsible Party: Nazmy Edward Seif, Clinical Professor, Cairo University
ClinicalTrials.gov Identifier: NCT04518215    
Other Study ID Numbers: USESPBPUAS
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nazmy Edward Seif, Cairo University:
Erector spinae plain block
Ultrasound-guided
Paediatric
 Upper abdominal surgery
Analgesia
Anesthesia