Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy

Not Applicable

Recruiting

• Conditions: Erector Spinae Plane Block; Children; Thoracoscopic Sympathectomy

• Registration Number: NCT06984874
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study Start: 2025-01-15
• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of pain	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Anesthetic consumption: minimum alveolar concentration	Intraoperatively	Anesthetic consumption: minimum alveolar concentration (MAC) of sevoflurane every 10 min using Anesthetic Consumption = Flow Rate × Concentration of Anesthetic in Vapor.
Diaphragmatic excursion	24 hours postoperatively	Diaphragmatic excursion will be recorded using ultrasound preoperatively and postoperatively.
Total analgesic consumption	24 hours postoperatively	Total analgesic consumption will be recorded.
Time to the first request for the rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia will be recorded from the end of surgery till first dose of meperidine administrated.
Recovery profile	24 hours postoperatively	Recovery profile will be recorded using Richmond Agitation and Sedation Scale (RASS) was required to be between - 3 and + 4 for a delirium classification (ISMV 4 only; RASS not collected in ISMV 3.
Incidence of complications	24 hours postoperatively	Incidence of complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, and respiratory depression will be recorded.

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt