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Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

NCT04518215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-02-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nazmy Edward Seif

    lead OTHER

Principal Investigators

  • Atef K Salama, MD · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  • Nazmy S Michael, MD · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2022-12-15
Completion
2022-12-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518215 on ClinicalTrials.gov