Interscalene BlockNCT07424638
Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain
A study testing Interscalene block, Anterior suprascapular block and Epidural analgesia in people with Interscalene Block and Anterior Suprascapular Block, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to compare the frequency of occurrence of ipsilateral shoulder pain in patients undergoing thoracotomy with ultrasound-guided interscalene block, anterior suprascapular block as adjunct to epidural and epidural block only. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interscalene Block, Anterior Suprascapular Block, Thoracotomy
- What is being tested?
- Interscalene block, Anterior suprascapular block and Epidural analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and ≤ 65 years old.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Body mass index 18-35 kg/m2.
- Patients who have a confirmed diagnosis of lung cancer and are scheduled for elective open-lung surgery.
Who cannot join
- Allergy to local anesthetics.
- Known psychiatric or neurologic disorders.
- Alcohol or narcotics abuse.
- Contraindications to thoracic epidural or suprascapular block, or interscalene block, e.g., coagulopathy or local infection.
- Pre-existing shoulder symptoms.
- History of previous thoracotomy.
- Severe restrictive or obstructive pulmonary disease.
- Pre-existing contralateral diaphragmatic paralysis.
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
Cairo University
Cairo, 12613
Mai M Elrawas, MD, 00201222177242, mai.elrawas@nci.cu.edu.eg
About this study
Official title: Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain: A Randomized Controlled Trial
This study aims to compare the frequency of occurrence of ipsilateral shoulder pain in patients undergoing thoracotomy with ultrasound-guided interscalene block, anterior suprascapular block as adjunct to epidural and epidural block only.
Read the detailed description
Thoracotomy is one type of surgery associated with challenging pain that needs to be promptly addressed to avoid post-operative respiratory complications and aid in effective postoperative physiotherapy and patient recovery. Epidural analgesia is considered the gold standard for the thoracotomy procedure. Ipsilateral shoulder pain (ISP) following thoracotomy has an incidence ranging from 37% to 85%.
Being so common, this pain needs more attention and proper anticipation, and management. ISP is usually non-responsive to the effects of epidural and paravertebral blocks.
- Being tested
- Interscalene block, Anterior suprascapular block, Epidural analgesia
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene blockOther
Patients will receive an ultrasound-guided interscalene block.
Anterior suprascapular blockOther
Patients will receive an ultrasound-guided anterior suprascapular block.
Epidural analgesiaOther
Patients will not receive regional blocks apart from epidural analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Group (I) | Experimental | Patients will receive an ultrasound-guided interscalene block. Receives: Other: Interscalene block |
| Group (S) | Experimental | Patients will receive an ultrasound-guided anterior suprascapular block. Receives: Other: Anterior suprascapular block |
| Group (E) | Active comparator | Patients will not receive regional blocks apart from epidural analgesia. Receives: Other: Epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of ipsilateral shoulder pain
Frequency of occurrence of ipsilateral shoulder pain will be recorded.
Measured: 72 hours postoperatively
Secondary outcomes (10)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be recorded after intensive care unit (ICU) admission then every 6 h postoperative for 72 h.
Measured: 72 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded every 30 minutes and immediately postoperative then every 4 h postoperative for 48 h.
Measured: 48 hours postoperatively
Heart rate
Heart rate will be recorded every 30 minutes and immediately postoperative then every 4 h postoperative for 48 h.
Measured: 48 hours postoperatively
Incidence of complications
Incidence of postoperative complications will be recorded.
Measured: 72 hours postoperatively
Time to first request of rescue analgesia
Rescue analgesia with 5 ml of 0.25% bupivacaine through the epidural catheter (in case of thoracotomy pain). Ketorolac 30 mg I.V. over 50 cc saline for breakthrough shoulder pain (will not exceed 120 mg/day).
Measured: 72 hours postoperatively
Total number of rescue analgesia
Total number of rescue analgesia will be recorded.
Measured: 72 hours postoperatively
Peak Expiratory Flow Rate
Peak Expiratory Flow Rate (PEFR) will be recorded as baseline in holding area before premedication and every 6 h postoperative for 72 h when visual analog scale (VAS) is ≤ 3.
Measured: 72 hours postoperatively
Forced Expiratory Volume in 1 second (FEV1)
Forced Expiratory Volume in 1 second (FEV1) will be recorded preoperative and at day 0, 1, 2 \& 3 when visual analog scale (VAS) is ≤ 3.
Measured: 72 hours postoperatively
Forced vital capacity (FVC)
Forced vital capacity (FVC) will be recorded preoperative and at day 0, 1, 2 \& 3 when visual analog scale (VAS) is ≤ 3.
Measured: 72 hours postoperatively
Forced Expiratory Volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio
Forced Expiratory Volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio will be recorded preoperative and at day 0, 1, 2 \& 3 when visual analog scale (VAS) is ≤ 3.
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start21 Feb 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interscalene BlockStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed El Rawas, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424638
- Sponsor's protocol ID
- AP2512-501-152-202
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07424638
- Acronym / sponsor ID
- AP2512-501-152-202
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 21 Feb 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 20 Feb 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.
This study aims to compare the frequency of occurrence of ipsilateral shoulder pain in patients undergoing thoracotomy with ultrasound-guided interscalene block, anterior suprascapular block as adjunct to epidural and epidural block only.
Detailed description
Thoracotomy is one type of surgery associated with challenging pain that needs to be promptly addressed to avoid post-operative respiratory complications and aid in effective postoperative physiotherapy and patient recovery. Epidural analgesia is considered the gold standard for the thoracotomy procedure. Ipsilateral shoulder pain (ISP) following thoracotomy has an incidence ranging from 37% to 85%.
Being so common, this pain needs more attention and proper anticipation, and management. ISP is usually non-responsive to the effects of epidural and paravertebral blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (I) | Experimental | Other: Interscalene blockPatients will receive an ultrasound-guided interscalene block. |
| Group (S) | Experimental | Other: Anterior suprascapular blockPatients will receive an ultrasound-guided anterior suprascapular block. |
| Group (E) | Active comparator | Other: Epidural analgesiaPatients will not receive regional blocks apart from epidural analgesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years and ≤ 65 years old.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Body mass index 18-35 kg/m2.
- Patients who have a confirmed diagnosis of lung cancer and are scheduled for elective open-lung surgery.
Key exclusion criteria (8 listed)
- Allergy to local anesthetics.
- Known psychiatric or neurologic disorders.
- Alcohol or narcotics abuse.
- Contraindications to thoracic epidural or suprascapular block, or interscalene block, e.g., coagulopathy or local infection.
- Pre-existing shoulder symptoms.
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 blockPatients will receive an ultrasound-guided interscalene block. | Other | Group (I) |
| Anterior suprascapular blockPatients will receive an ultrasound-guided anterior suprascapular block. | Other | Group (S) |
| Epidural analgesiaPatients will not receive regional blocks apart from epidural analgesia. | Other | Group (E) |
Primary outcome
Frequency of occurrence of ipsilateral shoulder pain
Time frame: 72 hours postoperatively
Frequency of occurrence of ipsilateral shoulder pain will be recorded.
10 secondary outcomes
Degree of pain
Time frame: 72 hours postoperatively
Mean arterial pressure
Time frame: 48 hours postoperatively
Heart rate
Time frame: 48 hours postoperatively
Incidence of complications
Time frame: 72 hours postoperatively
Time to first request of rescue analgesia
Time frame: 72 hours postoperatively
Total number of rescue analgesia
Time frame: 72 hours postoperatively
Peak Expiratory Flow Rate
Time frame: 72 hours postoperatively
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 72 hours postoperatively
Forced vital capacity (FVC)
Time frame: 72 hours postoperatively
Forced Expiratory Volume in 1 second (FEV1) / Forced vital capacity (FVC) ratio
Time frame: 72 hours postoperatively
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 24 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene block, Anterior suprascapular block and Epidural analgesia in people with Interscalene Block and Anterior Suprascapular Block, run by National Cancer Institute, Egypt 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 4 inclusion and 8 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 24 Feb 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.
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 Mai M Elrawas, MD (00201222177242, mai.elrawas@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of occurrence of ipsilateral shoulder pain (time frame: 72 hours postoperatively). 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 24 Feb 2026.