Nerve Block/Methods
Conditions
Keywords
Post-Thoracotomy Ipsilateral Shoulder Pain, Suprascapular Nerve Block, Interscalene block, Regional Analgesia, postoperative opioid consumption, Nerve block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREInterscalene brachial plexus block
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.
PROCEDUREanterior Supraclavicular nerve block
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.
OTHERThoracic Epidural Analgesia (TEA) only
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.
Sponsors
Children's Cancer Hospital Egypt 57357
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, randomized, controlled clinical trial phase III will be conducted in pediatric patients aged 5-18 yrs. undergoing elective thoracotomy at children's cancer hospital 57357. Patients will be randomized into three groups using block stratified software: Group A: Thoracic epidural analgesia + Interscalene brachial plexus block. Group B: Thoracic epidural analgesia + anterior Supraclavicular nerve block. Group C: Thoracic epidural analgesia only (control group). Either interscalene or supraclavicular nerve block will be done pre-emptive after induction of anesthesia with 0.25% bupivacaine with maximum dose of 2mg/kg. Pain scores, opioid requirements, and adverse effects will be recorded over the first 24 postoperative hours. The effectiveness of suprascapular nerve block and Interscalene brachial plexus nerve block in reducing ipsilateral shoulder pain after thoracotomy using VAS score.
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS score) | 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
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid consumption | 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. |
| Incidence of adverse effects | 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. |
Countries
Egypt
Contacts
CONTACTNancy Ashraf Abdellatif
CONTACTDina Elgalaly
PRINCIPAL_INVESTIGATORSuzan Adlan Khedr
Children's cancer hospital 57357
Outcome results
None listed