AnesthesiaNCT06208774
Pericapsular Nerve Group Block vs Interscalene Block for Shoulder Arthroscopy
A study testing Ultrasound-guided PENG or ISBP block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare PENG block and LV-ISBP block in the incidence of phrenic nerve block, duration of postoperative analgesia, time to first analgesic request (VAS > 30 mm), pain scores, and side effects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia, Regional Anesthesia Morbidity, Shoulder Pain
- What is being tested?
- Ultrasound-guided PENG or ISBP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for shoulder arthroscopy
- American Society of Anesthesiologists (ASA) status I and II
- Ages between 18 and 60 years.
Who cannot join
- Coagulopathy
- Infection at the injection site.
- Allergy to local anesthetics
- Severe cardiopulmonary disease (≥ASA III)
- Diabetic or other neuropathies
- Motor disorders
- Patients receiving opioids for chronic analgesic therapy.
- Inability to comprehend visual analogue scale (VAS).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university Hospitals. kasralainy
Cairo, Governorate, 002
Nagy malak, 01552480258, nagymalak12345@gmail.com
About this study
Official title: Pericapsular Nerve Group Block vs Low Volume Interscalene Brachial Plexus Block for Shoulder Arthroscopy: A Randomized Controlled Trial
This study aims to compare PENG block and LV-ISBP block in the incidence of phrenic nerve block, duration of postoperative analgesia, time to first analgesic request (VAS > 30 mm), pain scores, and side effects.
Read the detailed description
This randomized, controlled, double-blinded trial will be conducted in a Cairo University hospital.On arrival of the patients in the regional anesthesia room, they will be secured with a 20-gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).
Before receiving the blocks, patients will be randomly assigned to one of the two study groups for diaphragmatic movement assessment:
The diaphragmatic excursion will be measured in the supine position before the block and after surgery by a blinded operator. A curvilinear ultrasound probe (5-7 MHz) will be placed at the subcostal area in the anterior axillary line, below the costal margin of the eighth and ninth ribs. The probe will be directed medially, cephalad, and dorsally to make the ultrasound beam reach the posterior third of the diaphragm perpendicularly. The probe will then be scanned along the long axis of the intercostal spaces, using the liver as the acoustic window on the right side and the spleen as the acoustic window on the left side. The M-mode sampling line will be positioned perpendicularly to the diaphragm, and the diaphragmatic excursions could be measured during quiet and deep breathing. The distance between the resting expiratory position and the maximum deep inspiration position will be measured. The measurement will be repeated three times, and the average value will be taken.
After measurement of diaphragmatic excursion, patients will receive either a PENG block or an LV-ISBP block before induction of general anesthesia, and to achieve double blinding, patients will receive the block by consultant anesthesiologists who have experience in regional anesthesia. Another doctor not involved in the block procedure will evaluate the patient intraoperatively and postoperatively.
PENG block group (n = 40): this group will receive an ultrasound-guided pericapsular nerve group block for the shoulder with a total volume of 20 mL and 0.5% bupivacaine.
LV-ISBP block group (n = 40): this group will receive ultrasound-guided low-volume interscalene brachial plexus block with a total volume of 5 mL and 0.5% bupivacaine.
Technique of PENG Block:
The technique of ultrasound-guided PENG block will be performed with the patient's arm placed in external rotation and abducted at 45 degrees. A linear ultrasound probe (4-12 MHz) will be placed longitudinally between the coracoid and the humeral head, visualizing the deltoid muscle and subscapularis tendon. A 22-gauge needle will be advanced in-plane, into the fascial plane between the deltoid muscle and subscapularis tendon. The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes with 3 ml of normal saline. After negative aspiration, a total of 20 mL of bupivacaine 0.5% will be injected in the fascial plane incrementally, aspirating every 5 ml.
Technique of the LV-ISBP block:
The technique of ultrasound-guided LV-ISBP will be performed with the patient in a semi-sitting position with the head tilted to the opposite side of the injection site. A linear ultrasound probe (4-12 MHz) will be placed parallel to the clavicle in the supraclavicular fossa, and the subclavian artery will be seen beating above the first rib. Then the probe will be moved cranially to identify the transverse process of the C7 vertebra at the level of the brachial plexus roots between the scalenus anterior and medius muscles. A volume of 2 mL of 2% lignocaine will be infiltrated subcutaneously before the block. The needle will be inserted in a plane approach from lateral to medial to scalenus medius and C5-C6 brachial plexus roots. The location of the needle tip will be confirmed by hydrodissection with 1 ml of normal saline. After negative aspiration, a total of 5 mL of bupivacaine 0.5% will be injected incrementally, aspirating every 2.5 mL.
To ensure blind assessment, a dressing will be placed to cover a standard area that will cover the puncture sites regardless of which block is performed.
In the operating room, induction of general anesthesia will be induced after adequate preoxygenation using 1 µg/kg fentanyl, 2 mg/kg propofol, and 0.5 mg/kg atracurium, in addition to 8mg IV dexamethasone for the prevention of postoperative nausea and vomiting. Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of isoflurane with oxygen (50%) in the air, and 0.1 mg/kg of atracurium will be administered every 20 minutes as maintenance anesthetic drugs. Volume-controlled ventilation will be maintained, and the respiratory rate will be adapted to maintain ET CO2 between 35 and 40 mmHg. Monitoring through ECG, NIBP, pulse oximetry, and capnography (ETCO2) continued throughout the surgeries. Each portal skin of the arthroscopy will be infiltrated by the surgeon with approximately 4 mL of 0.25% bupivacaine. Intraoperative inadequate analgesia, indicated by an increase in HR or mean arterial blood pressure (MAP) more than 20% above preinduction baseline values, will be managed using incremental 50-microgram doses of fentanyl. Intraoperative fentanyl consumption will be calculated. All patients will receive ketorolac 30mg IV and paracetamol 1 mg for postoperative analgesia. At the end of surgery, muscle relaxants will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Awake extubation will be established after adequate reversal of the neuromuscular block.
Patients will be transported to the post-anesthesia care unit (PACU) for one hour before being shifted to the ward. In the PACU, after the patient regains full consciousness, the diaphragmatic movement will be reassessed in the exact same manner as preoperatively. Phrenic nerve block is defined as failure of the diaphragm to achieve 25% of the pre-block excursion value.
Postoperative pain will be assessed using VAS (where 0 corresponds to no pain and 100 mm to the worst pain) at 2, 4, 6, 12, 18, and 24 hours postoperatively.
Postoperatively, in the ward, all patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h. If the VAS score is > 30 mm, IV morphine increments (2 mg) will be given to maintain VAS ≤ 30 mm with a maximum total 24-hour morphine consumption of 10 mg, and total morphine consumption will be recorded.
- Conditions
- Anesthesia, Regional Anesthesia Morbidity, Shoulder Pain, Arthroscopy
- Being tested
- Ultrasound-guided PENG or ISBP block
- Keywords
- Shoulder, PENG, Interscalene block, Arthroscopy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided PENG or ISBP blockProcedure or surgery
The diaphragmatic excursion will be measured in the supine position before the block and after surgery. A curvilinear US probe (5-7 MHz) will be placed at the subcostal area in the anterior axillary line, below the costal margin of the eighth and ninth ribs. The probe will be directed medially, cephalad, and dorsally to make the US beam reach the posterior third of the diaphragm perpendicularly. The probe will then be scanned along the long axis of the intercostal spaces, using the liver as the acoustic window on the right side and the spleen as on the left side. M-mode sampling line will be positioned perpendicularly to the diaphragm, and the diaphragmatic excursions could be measured during quiet and deep breathing.The measurement will be repeated three times, and the average value will be taken. After measurement of diaphragmatic excursion, patients will receive either a PENG block or an LV-ISBP block before induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| LV-ISBP block Group (n=40): US-guided low volume interscalene brachial plexus block | Experimental | Patient in a semi-sitting position with the head tilted to the opposite side of the injection site. A linear US probe (4-12 MHz) will be placed parallel to the clavicle in the supraclavicular fossa, and the subclavian artery will be seen beating above the first rib.Then the probe will be moved cranially to identify the transverse process of the C7 vertebra at the level of the brachial plexus roots between the scalenus anterior and medius muscles.The needle will be inserted in a plane approach from lateral to medial to scalenus medius and C5-C6 brachial plexus roots. After negative aspiration, a total of 5 mL of bupivacaine 0.5% will be injected incrementally. Receives: Procedure: Ultrasound-guided PENG or ISBP block |
| PENG block Group (n=40): US-guided pericapsular nerve group block for shoulder | Active comparator | The patient's arm was placed in external rotation and abducted at 45 degrees. A linear US probe (4-12 MHz) will be placed longitudinally between the coracoid and the humeral head, visualizing the deltoid muscle and subscapularis tendon. 22-gauge needle will be advanced in-plane into the fascial plane between the deltoid muscle and subscapularis tendon. The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes with 3 ml of normal saline. After negative aspiration, a total of 20 mL of bupivacaine 0.5% will be injected in the fascial plane incrementally, aspirating every 5 ml. Receives: Procedure: Ultrasound-guided PENG or ISBP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of phrenic nerve block
Incidence of phrenic nerve block
Measured: 24 hours
Secondary outcomes (4)
First analgesic request
Time to first analgesic request (Visual analogue pain> 40 mm)
Measured: 24 hours postoperative
Visual analogue pain score
Visual analogue pain score for pain assessment (from 0 the Best to 100 the worst) at 2, 4, 6, 12, 18, and 24 hours postoperatively
Measured: 24 hours postoperatively.
Total morphine requirements
Total morphine requirements 24 hours postoperatively.
Measured: 24 hours
Type and time of surgery
Type and time of surgery
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start20 Dec 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagy Malak , MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208774
- Sponsor's protocol ID
- N-403-2023
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Block vs Low Volume Interscalene Brachial Plexus Block for Shoulder Arthroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06208774
- Acronym / sponsor ID
- N-403-2023
- Conditions
- Anesthesia, Regional Anesthesia Morbidity, Shoulder Pain, Arthroscopy
- Keywords
- Shoulder, PENG, Interscalene block, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 17 Jan 2024 (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 PENG block and LV-ISBP block in the incidence of phrenic nerve block, duration of postoperative analgesia, time to first analgesic request (VAS > 30 mm), pain scores, and side effects.
Detailed description
This randomized, controlled, double-blinded trial will be conducted in a Cairo University hospital.On arrival of the patients in the regional anesthesia room, they will be secured with a 20-gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).
Before receiving the blocks, patients will be randomly assigned to one of the two study groups for diaphragmatic movement assessment:
The diaphragmatic excursion will be measured in the supine position before the block and after surgery by a blinded operator. A curvilinear ultrasound probe (5-7 MHz) will be placed at the subcostal area in the anterior axillary line, below the costal margin of the eighth and ninth ribs. The probe will be directed medially, cephalad, and dorsally to make the ultrasound beam reach the posterior third of the diaphragm perpendicularly. The probe will then be scanned along the long axis of the intercostal spaces, using the liver as the acoustic window on the right side and the spleen as the acoustic window on the left side. The M-mode sampling line will be positioned perpendicularly to the diaphragm, and the diaphragmatic excursions could be measured during quiet and deep breathing. The distance between the resting expiratory position and the maximum deep inspiration position will be measured. The measurement will be repeated three times, and the average value will be taken.
After measurement of diaphragmatic excursion, patients will receive either a PENG block or an LV-ISBP block before induction of general anesthesia, and to achieve double blinding, patients will receive the block by consultant anesthesiologists who have experience in regional anesthesia. Another doctor not involved in the block procedure will evaluate the patient intraoperatively and postoperatively.
PENG block group (n = 40): this group will receive an ultrasound-guided pericapsular nerve group block for the shoulder with a total volume of 20 mL and 0.5% bupivacaine.
LV-ISBP block group (n = 40): this group will receive ultrasound-guided low-volume interscalene brachial plexus block with a total volume of 5 mL and 0.5% bupivacaine.
Technique of PENG Block:
The technique of ultrasound-guided PENG block will be performed with the patient's arm placed in external rotation and abducted at 45 degrees. A linear ultrasound probe (4-12 MHz) will be placed longitudinally between the coracoid and the humeral head, visualizing the deltoid muscle and subscapularis tendon. A 22-gauge needle will be advanced in-plane, into the fascial plane between the deltoid muscle and subscapularis tendon. The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes with 3 ml of normal saline. After negative aspiration, a total of 20 mL of bupivacaine 0.5% will be injected in the fascial plane incrementally, aspirating every 5 ml.
Technique of the LV-ISBP block:
The technique of ultrasound-guided LV-ISBP will be performed with the patient in a semi-sitting position with the head tilted to the opposite side of the injection site. A linear ultrasound probe (4-12 MHz) will be placed parallel to the clavicle in the supraclavicular fossa, and the subclavian artery will be seen beating above the first rib. Then the probe will be moved cranially to identify the transverse process of the C7 vertebra at the level of the brachial plexus roots between the scalenus anterior and medius muscles. A volume of 2 mL of 2% lignocaine will be infiltrated subcutaneously before the block. The needle will be inserted in a plane approach from lateral to medial to scalenus medius and C5-C6 brachial plexus roots. The location of the needle tip will be confirmed by hydrodissection with 1 ml of normal saline. After negative aspiration, a total of 5 mL of bupivacaine 0.5% will be injected incrementally, aspirating every 2.5 mL.
To ensure blind assessment, a dressing will be placed to cover a standard area that will cover the puncture sites regardless of which block is performed.
In the operating room, induction of general anesthesia will be induced after adequate preoxygenation using 1 µg/kg fentanyl, 2 mg/kg propofol, and 0.5 mg/kg atracurium, in addition to 8mg IV dexamethasone for the prevention of postoperative nausea and vomiting. Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of isoflurane with oxygen (50%) in the air, and 0.1 mg/kg of atracurium will be administered every 20 minutes as maintenance anesthetic drugs. Volume-controlled ventilation will be maintained, and the respiratory rate will be adapted to maintain ET CO2 between 35 and 40 mmHg. Monitoring through ECG, NIBP, pulse oximetry, and capnography (ETCO2) continued throughout the surgeries. Each portal skin of the arthroscopy will be infiltrated by the surgeon with approximately 4 mL of 0.25% bupivacaine. Intraoperative inadequate analgesia, indicated by an increase in HR or mean arterial blood pressure (MAP) more than 20% above preinduction baseline values, will be managed using incremental 50-microgram doses of fentanyl. Intraoperative fentanyl consumption will be calculated. All patients will receive ketorolac 30mg IV and paracetamol 1 mg for postoperative analgesia. At the end of surgery, muscle relaxants will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Awake extubation will be established after adequate reversal of the neuromuscular block.
Patients will be transported to the post-anesthesia care unit (PACU) for one hour before being shifted to the ward. In the PACU, after the patient regains full consciousness, the diaphragmatic movement will be reassessed in the exact same manner as preoperatively. Phrenic nerve block is defined as failure of the diaphragm to achieve 25% of the pre-block excursion value.
Postoperative pain will be assessed using VAS (where 0 corresponds to no pain and 100 mm to the worst pain) at 2, 4, 6, 12, 18, and 24 hours postoperatively.
Postoperatively, in the ward, all patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h. If the VAS score is > 30 mm, IV morphine increments (2 mg) will be given to maintain VAS ≤ 30 mm with a maximum total 24-hour morphine consumption of 10 mg, and total morphine consumption will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LV-ISBP block Group (n=40): US-guided low volume interscalene brachial plexus block | Experimental | Procedure: Ultrasound-guided PENG or ISBP blockPatient in a semi-sitting position with the head tilted to the opposite side of the injection site. A linear US probe (4-12 MHz) will be placed parallel to the clavicle in the supraclavicular fossa, and the subclavian artery will be seen beating above the first rib.Then the probe will be moved cranially to identify the transverse process of the C7 vertebra at the level of the brachial plexus roots between the scalenus anterior and medius muscles.The needle will be inserted in a plane approach from lateral to medial to scalenus medius and C5-C6 brachial plexus roots. After negative aspiration, a total of 5 mL of bupivacaine 0.5% will be injected incrementally. |
| PENG block Group (n=40): US-guided pericapsular nerve group block for shoulder | Active comparator | Procedure: Ultrasound-guided PENG or ISBP blockThe patient's arm was placed in external rotation and abducted at 45 degrees. A linear US probe (4-12 MHz) will be placed longitudinally between the coracoid and the humeral head, visualizing the deltoid muscle and subscapularis tendon. 22-gauge needle will be advanced in-plane into the fascial plane between the deltoid muscle and subscapularis tendon. The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes with 3 ml of normal saline. After negative aspiration, a total of 20 mL of bupivacaine 0.5% will be injected in the fascial plane incrementally, aspirating every 5 ml. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for shoulder arthroscopy
- American Society of Anesthesiologists (ASA) status I and II
- Ages between 18 and 60 years.
Key exclusion criteria (8 listed)
- Coagulopathy
- Infection at the injection site.
- Allergy to local anesthetics
- Severe cardiopulmonary disease (≥ASA III)
- Diabetic or other neuropathies
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 |
|---|---|---|
| Ultrasound-guided PENG or ISBP blockThe diaphragmatic excursion will be measured in the supine position before the block and after surgery. A curvilinear US probe (5-7 MHz) will be placed at the subcostal area in the anterior axillary line, below the costal margin of the eighth and ninth ribs. The probe will be directed medially, cephalad, and dorsally to make the US beam reach the posterior third of the diaphragm perpendicularly. The probe will then be scanned along the long axis of the intercostal spaces, using the liver as the acoustic window on the right side and the spleen as on the left side. M-mode sampling line will be positioned perpendicularly to the diaphragm, and the diaphragmatic excursions could be measured during quiet and deep breathing.The measurement will be repeated three times, and the average value will be taken. After measurement of diaphragmatic excursion, patients will receive either a PENG block or an LV-ISBP block before induction of general anesthesia. | Procedure or surgery | LV-ISBP block Group (n=40): US-guided low volume interscalene brachial plexus block, PENG block Group (n=40): US-guided pericapsular nerve group block for shoulder |
Primary outcome
Incidence of phrenic nerve block
Time frame: 24 hours
Incidence of phrenic nerve block
4 secondary outcomes
First analgesic request
Time frame: 24 hours postoperative
Visual analogue pain score
Time frame: 24 hours postoperatively.
Total morphine requirements
Time frame: 24 hours
Type and time of surgery
Time frame: up to 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided PENG or ISBP block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University 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 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagy malak, MD (01552480258, nagymalak1234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of phrenic nerve block (time frame: 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 17 Jan 2024.