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NCT Number: NCT06984874

Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy

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.

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Key information

Conditions

Erector Spinae Plane Block Children Thoracoscopic Sympathectomy

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Location status: Recruiting

Location contact

Amany S Ammar, MD

SUB_INVESTIGATOR

Asmaa I Salamah, MD

SUB_INVESTIGATOR

Khaled M Gaballah, MD

SUB_INVESTIGATOR

Safaa M Sallam, Master

CONTACT

[email protected]

00201001876902

Wafiya R Mahdy, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erector spinae plane block

Other

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

General anesthesia

Other

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

Primary outcomes

  1. Degree of pain

    Time frame: 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 outcomes

  1. Total analgesic consumption

    Time frame: 24 hours postoperatively

    Total analgesic consumption will be recorded.

  2. Anesthetic consumption: minimum alveolar concentration

    Time frame: Intraoperatively

    Anesthetic consumption: minimum alveolar concentration (MAC) of sevoflurane every 10 min using Anesthetic Consumption = Flow Rate × Concentration of Anesthetic in Vapor.

  3. Diaphragmatic excursion

    Time frame: 24 hours postoperatively

    Diaphragmatic excursion will be recorded using ultrasound preoperatively and postoperatively.

  4. Time to the first request for the rescue analgesia

    Time frame: 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.

  5. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, and respiratory depression will be recorded.

  6. Recovery profile

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Safaa M Sallam, Master

CONTACT

[email protected]

00201001876902

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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