Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

NCT04518215 | Completed

• 1 other identifier: USESPBPUAS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Paediatric; Surgery; Analgesia; Anesthesia

Keywords

Erector spinae plain block; Ultrasound-guided; Paediatric; Upper abdominal surgery; Analgesia; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Tramadol consumption.

  Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively.

  24 hours

Study Arms (2)

ESPB group

EXPERIMENTAL

Erector Spinae Plain Block

Procedure: Erector Spinae Plain Block; Procedure: Intra-Venous Analgesia

IV Analgesia group

ACTIVE COMPARATOR

Intra-Venous Analgesia

Procedure: Intra-Venous Analgesia

Interventions

Erector Spinae Plain Block PROCEDURE

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.

ESPB group

Intra-Venous Analgesia PROCEDURE

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.

ESPB group; IV Analgesia group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patient's next of kin refusal.
• Allergy to local anaesthetics.
• Infection at the site of injection.
• Coagulopathy.

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Atef K Salama, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

• Nazmy S Michael, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 19, 2020
• Study Start: August 20, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

EG (1)