Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

Surgery Clinical Trial

Official title:

Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518215
• Other study ID #: USESPBPUAS
• Status: Completed
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: December 15, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Paediatric
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tramadol consumption.	Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively.	24 hours