Proximal Humerus FracturesNCT06253442
Comparison Between Interscalene Block and Combined Suprascapular and Axillary Blocks for Proximal Humerus Fracture Surgeries.
A study testing Patients will receive Supra scapular nerve block and Axillary nerve block. and Patients will receive Interscalene block. in people with Proximal Humerus Fractures, run by Ain Shams University at 1 site in Egypt.
Trial summary
A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries. The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Proximal Humerus Fractures
- What is being tested?
- Patients will receive Supra scapular nerve block and Axillary nerve block. and Patients will receive Interscalene block.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 15 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 18 to 65 years.
- Both sexes.
- Patients scheduled for proximal humerus fracture surgeries.
Who cannot join
- Patient refusal
- ASA physical status III or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with history of cardiovascular disease.
- Patients with renal disease.
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- Patients with hepatic disease.
- Patients with neuromuscular disease.
- Presence of any coagulopathy.
- Chronic opioid, gabapentin or pregabalin use.
- Patients with history of any psychiatric disorder.
- BMI more than 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Ultrasound Guided Interscalene Block and Combined Ultrasound Guided Suprascapular and Axillary Nerve Blocks for Proximal Humerus Fracture Surgeries.
A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries.
The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.
Read the detailed description
A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries.
The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.
- Conditions
- Proximal Humerus Fractures
- Being tested
- Patients will receive Supra scapular nerve block and Axillary nerve block., Patients will receive Interscalene block.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive Supra scapular nerve block and Axillary nerve block.Procedure or surgery
Suprascapular nerve block will be done by posterior approach with the patient sitting up and leaning forward. The linear ultrasound probe will identify the suprascapular nerve, after that we will inject aliquots of Sunnypivacaine 0.5% 15 ml after negative aspiration of blood.
For the axillary nerve block, the ultrasound transducer will be placed in a sagittal plane over the humeral head on the posterior aspect of the arm to identify the deltoid muscle, neck of the humerus, the teres minor muscle, the circumflex humeral artery, and the triceps muscle. After the neurovascular quadrangular space identification and observing the deltoid muscle response to stimulation, a local anesthetic (10 ml 0.25% Sunnypivacaine) will be injected with the in-plain technique.
Patients will receive Interscalene block.Procedure or surgery
Interscalene nerve block will be done ultrasound-guided using a linear array ultrasound transducer. While the patient is in the supine position, the head will be rotated to the contralateral side of the block. Ultrasound scanning will be performed in the transverse plane with long axis of the probe parallel to clavicle to visualize the brachial plexus between the anterior and middle scalene muscles. A 5-cm 22-gauge insulated needle will then be inserted in line with the probe in a lateral-to-medial needle orientation. Local anesthetic solution will then be injected in 15-ml aliquots Sunnypivacaine 0.5% after negative aspiration for blood to achieve spread posterior to or between the C5 and C6 nerve roots.
| Study group | Role | What they receive |
|---|---|---|
| Patients will receive Supra scapular nerve block and Axillary nerve block. | Active comparator | ultrasound guided suprascapular nerve block combined with ultrasound guided axillary nerve block will be provided to the patient Receives: Procedure: Patients will receive Supra scapular nerve block and Axillary nerve block. |
| Patients will receive Interscalene block. | Active comparator | ultrasound guided interscalene brachial plexus block will be provided to the patient Receives: Procedure: Patients will receive Interscalene block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
Measured: 24 HOURS
The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.
The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.
Measured: 24 HOURS
Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).
Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).
Measured: 24 HOURS
Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.
Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start10 Feb 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus FracturesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, riham fathy galal, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253442
- Sponsor's protocol ID
- FAMSU R10/2024
- Status last verified
- Sep 2024
- First submitted
- 30 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound Guided Interscalene Block and Combined Ultrasound Guided Suprascapular and Axillary Nerve Blocks for Proximal Humerus Fracture Surgeries.
- ClinicalTrials.gov ID
- NCT06253442
- Acronym / sponsor ID
- FAMSU R10/2024
- Conditions
- Proximal Humerus Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 12 Feb 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.
A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries.
The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.
Detailed description
A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries.
The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients will receive Supra scapular nerve block and Axillary nerve block. | Active comparator | Procedure: Patients will receive Supra scapular nerve block and Axillary nerve block.ultrasound guided suprascapular nerve block combined with ultrasound guided axillary nerve block will be provided to the patient |
| Patients will receive Interscalene block. | Active comparator | Procedure: Patients will receive Interscalene block.ultrasound guided interscalene brachial plexus block will be provided to the patient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 18 to 65 years.
- Both sexes.
- Patients scheduled for proximal humerus fracture surgeries.
Key exclusion criteria (12 listed)
- Patient refusal
- ASA physical status III or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with history of cardiovascular disease.
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 |
|---|---|---|
| Patients will receive Supra scapular nerve block and Axillary nerve block.Suprascapular nerve block will be done by posterior approach with the patient sitting up and leaning forward. The linear ultrasound probe will identify the suprascapular nerve, after that we will inject aliquots of Sunnypivacaine 0.5% 15 ml after negative aspiration of blood. For the axillary nerve block, the ultrasound transducer will be placed in a sagittal plane over the humeral head on the posterior aspect of the arm to identify the deltoid muscle, neck of the humerus, the teres minor muscle, the circumflex humeral artery, and the triceps muscle. After the neurovascular quadrangular space identification and observing the deltoid muscle response to stimulation, a local anesthetic (10 ml 0.25% Sunnypivacaine) will be injected with the in-plain technique. | Procedure or surgery | Patients will receive Supra scapular nerve block and Axillary nerve block. |
| Patients will receive Interscalene block.Interscalene nerve block will be done ultrasound-guided using a linear array ultrasound transducer. While the patient is in the supine position, the head will be rotated to the contralateral side of the block. Ultrasound scanning will be performed in the transverse plane with long axis of the probe parallel to clavicle to visualize the brachial plexus between the anterior and middle scalene muscles. A 5-cm 22-gauge insulated needle will then be inserted in line with the probe in a lateral-to-medial needle orientation. Local anesthetic solution will then be injected in 15-ml aliquots Sunnypivacaine 0.5% after negative aspiration for blood to achieve spread posterior to or between the C5 and C6 nerve roots. | Procedure or surgery | Patients will receive Interscalene block. |
Primary outcome
Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
Time frame: 24 HOURS
Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.
Time frame: 24 HOURS
The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.
Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).
Time frame: 24 HOURS
Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).
Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.
Time frame: 24 hours
Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will receive Supra scapular nerve block and Axillary nerve block. and Patients will receive Interscalene block. in people with Proximal Humerus Fractures, run by Ain Shams 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 19 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable). (time frame: 24 HOURS). The study lists 4 primary outcomes in all. 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 19 Sep 2024.