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NCT Number: NCT07796399

Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.

The goal of this clinical trial is to determine which regional block provides superior analgesia in pediatric patients undergoing thoracic surgery. The main questions it aims to answer are:

* Does one block technique provide better pain relief? * Does the choice of block reduce opioid requirements and complication rates? Researchers will compare two block techniques to see if one offers an effective opioid-sparing strategy that improves patient comfort and reduces side effects.

Participants will:

* Receive one of the studied block interventions during thoracic surgery. * Be monitored for postoperative pain scores, opioid consumption, and any complications.

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Key information

Conditions

Nerve Block/Methods

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children's Cancer Hospital 57357

Cairo, Egypt, 11617

Location status: Recruiting

Location contact

Dina elgalaly

CONTACT

[email protected]

2025351500

About this study

This prospective randomized controlled trial aims to evaluate and compare the effectiveness and safety of two regional analgesic techniques-suprascapular nerve block (SSNB) and interscalene brachial plexus block (ISB)-for managing ipsilateral shoulder pain (ISP) following pediatric thoracotomy. ISP is a common and distressing postoperative complication, affecting 30-85% of thoracotomy patients, and is often poorly responsive to systemic opioids and thoracic epidural analgesia due to its referred pain origin via the phrenic and suprascapular nerves.

Identifying effective targeted analgesic strategies is therefore clinically important. The study will be conducted at Children's Cancer Hospital 57357 and will include 126 pediatric patients (5-18 years, ASA II-III) undergoing elective open thoracotomy.

Participants will be randomized into three groups:

  • Thoracic epidural analgesia plus interscalene block.
  • Thoracic epidural analgesia plus suprascapular nerve block.
  • Thoracic epidural analgesia alone (control). Ultrasound-guided regional blocks will be administered using 0.25% bupivacaine (maximum 2 mg/kg) on the operative side. Postoperative pain scores will be assessed using the Numeric Rating Scale at 2, 4, 6, 12, and 24 hours, alongside total opioid consumption and adverse event monitoring.

The primary objective is to compare the analgesic efficacy of SSNB and ISB in reducing ISP after thoracotomy, while secondary outcomes include postoperative opioid requirements and complication rates. This study is significant because it addresses a persistent clinical challenge in pediatric thoracic surgery pain management. By identifying an effective opioid-sparing regional analgesic technique, the findings may improve postoperative comfort, reduce opioid-related side effects, enhance recovery, and inform evidence-based postoperative pain management protocols for pediatric thoracotomy patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status II-III
  • Elective open thoracotomy

Exclusion criteria

  • Pre-existing shoulder pathology
  • Coagulopathy or infection at injection site
  • Allergy to local anesthetics
  • Neurological disorders involving upper limb

Treatment and study plan

Interscalene brachial plexus block

Procedure

regional anesthesia technique performed at the level of the upper trunks of the brachial plexus to provide pain relief and anesthesia for surgeries involving the shoulder, clavicle, and upper arm. It is commonly used in orthopedic and thoracic procedures where shoulder pain is significant.

anterior Supraclavicular nerve block

Procedure

is a regional anesthesia technique targeting the trunks of the brachial plexus just above the clavicle, providing rapid and dense anesthesia for surgeries of the upper limb below the shoulder. It is often referred to as the "spinal of the arm" because of its effectiveness in numbing the arm quickly.

Thoracic Epidural Analgesia (TEA) only

Other

Control- standard treatment. A regional anesthesia technique in which a local anesthetic (sometimes combined with opioids) is injected into the epidural space of the thoracic spine to block nerve transmission and provide pain relief.

Primary outcomes

  1. Visual Analogue Scale (VAS score)

    Time frame: Multiple intervals (2, 4, 6, 12, and 24 hours)

    VAS is a tool used to measure the intensity of pain or other subjective experiences.

    It is a 10-centimeter line, one end represents "no pain" (0), and the other end represents "worst imaginable pain" (10). The patient marks a point on the line that reflects their pain level.

    The score is then measured in centimeters or millimeters from the "no pain" end, giving a numerical value. Scores are collected at multiple intervals (2, 4, 6, 12, and 24 hours). This approach accounts for the repeated measurements and evaluates the interaction between the intervention groups and time.

    0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-9 = Severe pain 10 = Worst imaginable pain

Secondary outcomes

  1. Total postoperative opioid consumption

    Time frame: 24 hours postoperative

    Total postoperative opioid consumption will be compared across the three groups using a One-way ANOVA or the Kruskal-Wallis test, depending on the distribution of the data. Post-hoc pairwise comparisons will be conducted using Tukey's HSD or Dunn's test with Bonferroni correction to identify specific group differences.

  2. Incidence of adverse effects

    Time frame: 24 hours postoperative

    The incidence of adverse effects will be compared using the Chi-square test, which is a statistical method used to compare the incidence (frequency or proportion) of categorical outcomes across groups.

Study contacts

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

Dina Elgalaly

CONTACT

[email protected]

+0201154021119

Nancy Ashraf Abdellatif

CONTACT

[email protected]

+21141083507

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

Targeted Regional Analgesia for Post-Thoracotomy Ipsilateral Shoulder Pain in Pediatrics: Evaluating the Role of Suprascapular Nerve Block Versus Interscalene Block" A Randomized Controlled Study.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

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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