Nerve Block/MethodsPhase 2/3NCT07796399
Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.
A Phase 2/3 study testing Interscalene brachial plexus block, anterior Supraclavicular nerve block and Thoracic Epidural Analgesia (TEA) only in people with Nerve Block/Methods, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial 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?… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Nerve Block/Methods
- What is being tested?
- Interscalene brachial plexus block, anterior Supraclavicular nerve block and Thoracic Epidural Analgesia (TEA) only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jul 2026to 9 Apr 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA physical status II-III
- Elective open thoracotomy
Who cannot join
- Pre-existing shoulder pathology
- Coagulopathy or infection at injection site
- Allergy to local anesthetics
- Neurological disorders involving upper limb
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Children's Cancer Hospital 57357
Cairo, Egypt, 11617
Dina elgalaly, 2025351500, delgalaly@gmail.com
About this study
Official 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.
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.
Read the 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.
- Conditions
- Nerve Block/Methods
- Being tested
- Interscalene brachial plexus block, anterior Supraclavicular nerve block, Thoracic Epidural Analgesia (TEA) only
- Keywords
- Post-Thoracotomy Ipsilateral Shoulder Pain, Suprascapular Nerve Block, Interscalene block, Regional Analgesia, postoperative opioid consumption, Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
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 blockProcedure or surgery
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) onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | 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. Receives: Procedure: Interscalene brachial plexus block |
| group B | Experimental | 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. Receives: Procedure: anterior Supraclavicular nerve block |
| group C | Other | Thoracic epidural analgesia only. Control group Receives: Other: Thoracic Epidural Analgesia (TEA) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS score)
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
Measured: Multiple intervals (2, 4, 6, 12, and 24 hours)
Secondary outcomes (2)
Total postoperative opioid consumption
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.
Measured: 24 hours postoperative
Incidence of adverse effects
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.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start9 Jul 2026
- Primary completion9 Apr 2028 (estimated)
- Study completion9 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Block/MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suzan mohamed adlan, Children's Cancer Hospital Egypt 57357
- Investigators
- Suzan Adlan Khedr, Principal investigator, Children's cancer hospital 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796399
- Sponsor's protocol ID
- N-0072-004-026
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07796399
- Acronym / sponsor ID
- N-0072-004-026
- Conditions
- Nerve Block/Methods
- Keywords
- Post-Thoracotomy Ipsilateral Shoulder Pain, Suprascapular Nerve Block, Interscalene block, Regional Analgesia, postoperative opioid consumption, Nerve block
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 9 Apr 2028 (estimated)
- Study completion
- 9 Apr 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: Interscalene brachial plexus blockThoracic 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. |
| group B | Experimental | Procedure: anterior Supraclavicular nerve blockThoracic 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. |
| group C | Other | Other: Thoracic Epidural Analgesia (TEA) onlyThoracic epidural analgesia only. Control group |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ASA physical status II-III
- Elective open thoracotomy
Key exclusion criteria (4 listed)
- Pre-existing shoulder pathology
- Coagulopathy or infection at injection site
- Allergy to local anesthetics
- Neurological disorders involving upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus blockregional 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. | Procedure or surgery | group A |
| anterior Supraclavicular nerve blockis 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. | Procedure or surgery | group B |
| Thoracic Epidural Analgesia (TEA) onlyControl- 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. | Other | group C |
Primary outcome
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
2 secondary outcomes
Total postoperative opioid consumption
Time frame: 24 hours postoperative
Incidence of adverse effects
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzan Adlan Khedr principal investigator
Children's cancer hospital 57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Interscalene brachial plexus block, anterior Supraclavicular nerve block and Thoracic Epidural Analgesia (TEA) only in people with Nerve Block/Methods, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Ashraf Abdellatif (+21141083507, nancy.ashraf@57357.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS score) (time frame: Multiple intervals (2, 4, 6, 12, and 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.