Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.
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.
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nancy Ashraf Abdellatif
- Numer telefonu: +21141083507
- E-mail: nancy.ashraf@57357.com
Kopia zapasowa kontaktu do badania
- Nazwa: Dina Elgalaly
- Numer telefonu: +0201154021119
- E-mail: dina.elgalaly@57357.org
Lokalizacje studiów
-
-
Egypt
-
Cairo, Egypt, Egipt, 11617
- Rekrutacyjny
- Children's Cancer Hospital 57357
-
Kontakt:
- Dina elgalaly
- Numer telefonu: 2025351500
- E-mail: delgalaly@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: group A
Thoracic epidural analgesia + Interscalene brachial plexus block; will be done pre-emptive after induction of anesthesia with 0.25% bupivacaine with maximum dose of 2mg/kg.
|
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.
|
|
Eksperymentalny: group B
Thoracic epidural analgesia + anterior supraclavicular nerve block will be done pre-emptive after induction of anesthesia with 0.25% bupivacaine with maximum dose of 2mg/kg.
|
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.
|
|
Inny: group C
Thoracic epidural analgesia only.
Control group
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Visual Analogue Scale (VAS score)
Ramy czasowe: 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 |
Multiple intervals (2, 4, 6, 12, and 24 hours)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Total postoperative opioid consumption
Ramy czasowe: 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.
|
24 hours postoperative
|
|
Incidence of adverse effects
Ramy czasowe: 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.
|
24 hours postoperative
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Suzan Adlan Khedr, Children's Cancer Hospital 57357
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- N-0072-004-026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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