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Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy

Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy: A Prospective Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06984874
Enrollment
40
Registered
2025-05-22
Start date
2025-01-15
Completion date
2025-12-01
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Erector Spinae Plane Block, Thoracoscopic Sympathectomy

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.

Interventions

OTHERErector spinae plane block

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

OTHERGeneral anesthesia

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

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of pain24 hours postoperativelyPostoperative 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

MeasureTime frameDescription
Diaphragmatic excursion24 hours postoperativelyDiaphragmatic excursion will be recorded using ultrasound preoperatively and postoperatively.
Total analgesic consumption24 hours postoperativelyTotal analgesic consumption will be recorded.
Anesthetic consumption: minimum alveolar concentrationIntraoperativelyAnesthetic consumption: minimum alveolar concentration (MAC) of sevoflurane every 10 min using Anesthetic Consumption = Flow Rate × Concentration of Anesthetic in Vapor.
Incidence of complications24 hours postoperativelyIncidence of complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, and respiratory depression will be recorded.
Recovery profile24 hours postoperativelyRecovery 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.
Time to the first request for the rescue analgesia24 hours postoperativelyTime to the first request for the rescue analgesia will be recorded from the end of surgery till first dose of meperidine administrated.

Countries

Egypt

Contacts

Primary ContactSafaa M Sallam, Master
safaa.sallam@med.menofia.edu.eg00201001876902

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026