Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy

NCT06984874 | Recruiting

• 1 other identifier: 1/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the influence of ultrasound-guided erector spinae plane block on postoperative pain and diaphragmatic dysfunction in pediatric patients undergoing thoracoscopic sympathectomy.

Conditions

Erector Spinae Plane Block; Children; Thoracoscopic Sympathectomy

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  Postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed on arrival at the post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, and 24 h postoperatively.

  24 hours postoperatively

Secondary Outcomes (6)

• Total analgesic consumption

  24 hours postoperatively

• Anesthetic consumption: minimum alveolar concentration

  Intraoperatively

• Diaphragmatic excursion

  24 hours postoperatively

• Time to the first request for the rescue analgesia

  24 hours postoperatively

• Incidence of complications

  24 hours postoperatively

Study Arms (2)

Erector spinae plane block group

EXPERIMENTAL

Patients will receive bilateral erector spinae plane block after the induction of general anesthesia as a study group.

Other: Erector spinae plane block

Control group

ACTIVE COMPARATOR

Patients will not receive the block after the induction of general anesthesia as a control group.

Other: General anesthesia

Interventions

Erector spinae plane block OTHER

Patients will receive bilateral erector spinae plane block after the induction of general anesthesia as a study group.

Erector spinae plane block group

General anesthesia OTHER

Patients will not receive the block after the induction of general anesthesia as a control group.

Control group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 6 to 16 years.
• Either sexes (male or female).
• American Society of Anesthesiologists (ASA) physical status I-II.
• Scheduled for bilateral thoracoscopic sympathectomy under general anesthesia.

You may not qualify if:

• History of allergy to local anesthetics.
• Abnormal liver/kidney function.
• Severe spinal deformities.
• Bleeding or coagulation disorders.
• Skin damage or infection at the proposed puncture site.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Safaa M Sallam, Master

CONTACT

00201001876902; safaa.sallam@med.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Menoufia University, Egypt.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: January 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)