Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy

NCT ID: NCT06984874

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-12-01

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.

Detailed Description

Pain may occur after pediatric thoracic surgery in cases such as skin incision creation, rib traction, and drain placement, and in other cases, such as rib nerve injury. Such pain is highly unfavorable to pediatric patients' recovery as it may lead to reduced cough strength for clearing secretions, decreased functional residual capacity, and pulmonary complications such as atelectasis and pneumonia.

Erector spinae plane block (ESPB) is a novel trunk block to relieve chronic neuropathic pain. Since then, it has gained prominence as a regional anesthesia technique with the potential to revolutionize postoperative pain management, and it has been effectively administered not only for the management of perioperative pain for a wide variety of surgeries but also for the management of acute post-traumatic pain and chronic pain.

Conditions

Erector Spinae Plane Block; Children; Thoracoscopic Sympathectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Erector spinae plane block group

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

Group Type: EXPERIMENTAL

Erector spinae plane block

Intervention Type: OTHER

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

Control group

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

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: OTHER

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

Interventions

Erector spinae plane block

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

Intervention Type: OTHER

General anesthesia

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

SAFAA MOHAMED SALLAM

Assistant Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Menoufia University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Safaa M Sallam, Master

Role: CONTACT

safaa.sallam@med.menofia.edu.eg

00201001876902

Facility Contacts

Safaa M Sallam, Master

Role: primary

safaa.sallam@med.menofia.edu.eg

00201001876902

Other Identifiers

1/2025

Identifier Type: -

Identifier Source: org_study_id