Shoulder and Upper Arm InjuryNCT04941235
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
A study testing ultrasound and nerve stimulator in people with Shoulder and Upper Arm Injury, run by Minia University at 1 site in Egypt.
Trial summary
There are different techniques of interscalene brachial plexus block, we aimed to evaluate the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder and Upper Arm Injury
- What is being tested?
- ultrasound and nerve stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 31 Aug 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old.
- Sex: Both sexes.
- ASA I \& II.
Who cannot join
- - Patient refusal.
- Bleeding disorders.
- Damage or disease of the brachial plexus.
- ASA more than II.
- Pre-existing peripheral neuropathy.
- Patients with neuromuscular diseases.
Show all 9Show fewer
- Patients with known hypersensitivity to drugs of the study.
- Patients with local skin infection at the site of injection.
- Psychiatric diseases interfering with evaluation of the block.
Trial locations and contacts
1 site in 1 country.
About this study
There are different techniques of interscalene brachial plexus block, we aimed to evaluate the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general anesthesia.
Read the detailed description
Prospective randomized controlled study
There were 4 groups included in our study:
Group N: nerve stimulator guided interscalene brachial plexus block was done Group U: ultrasound guided interscalene brachial plexus block was done Group NU: dual guidance (using both nerve stimulator and ultrasound) Group C: control group We assessed in each group: heart rate, noninvasive blood pressure, time needed for block, onset of sensory and motor power loss and their offset, and finally patient satisfaction.
- Conditions
- Shoulder and Upper Arm Injury
- Being tested
- ultrasound and nerve stimulator
- Keywords
- shoulder arthroscopy
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound and nerve stimulatorDevice
nerve stimulator and ultrasound guided interscalene brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| NU group | Active comparator | Bth nerve stimulator and ultrasound guided interscalene brachial plexus block Receives: Device: ultrasound and nerve stimulator |
| U group | Active comparator | Ultrasound guided interscalene brachial plexus block Receives: Device: ultrasound and nerve stimulator |
| N group | Active comparator | Nerve stimulator guided interscalene brachial plexus block Receives: Device: ultrasound and nerve stimulator |
| C group | No intervention | No block only IV analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic effect of each technique
using visual analogue scale for pain The patient is asked to express the degree of pain in numbers from 0-10, where 0 means no pain and 10 represents severe pain.
Measured: 12 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 May 2018
- Primary completion1 May 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder and Upper Arm InjuryStudies of the same condition, open and under way.
- More trials run by Minia 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shery Shehata Kyriacos, Minia University
- Investigators
- Ahmed K Mohamed, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941235
- Sponsor's protocol ID
- 219:7/2019
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2021
- Last updated
- 30 Jun 2021
- 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT04941235
- Acronym / sponsor ID
- 219:7/2019
- Conditions
- Shoulder and Upper Arm Injury
- Keywords
- shoulder arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Jun 2021 (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.
There are different techniques of interscalene brachial plexus block, we aimed to evaluate the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general anesthesia.
Detailed description
Prospective randomized controlled study
There were 4 groups included in our study:
Group N: nerve stimulator guided interscalene brachial plexus block was done Group U: ultrasound guided interscalene brachial plexus block was done Group NU: dual guidance (using both nerve stimulator and ultrasound) Group C: control group We assessed in each group: heart rate, noninvasive blood pressure, time needed for block, onset of sensory and motor power loss and their offset, and finally patient satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NU group | Active comparator | Device: ultrasound and nerve stimulatorBth nerve stimulator and ultrasound guided interscalene brachial plexus block |
| U group | Active comparator | Device: ultrasound and nerve stimulatorUltrasound guided interscalene brachial plexus block |
| N group | Active comparator | Device: ultrasound and nerve stimulatorNerve stimulator guided interscalene brachial plexus block |
| C group | No intervention | –No block only IV analgesics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-65 years old.
- Sex: Both sexes.
- ASA I \& II.
Key exclusion criteria (9 listed)
- - Patient refusal.
- Bleeding disorders.
- Damage or disease of the brachial plexus.
- ASA more than II.
- Pre-existing peripheral neuropathy.
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 and nerve stimulatornerve stimulator and ultrasound guided interscalene brachial plexus block | Device | N group, NU group, U group |
Primary outcome
Analgesic effect of each technique
Time frame: 12 hour
using visual analogue scale for pain The patient is asked to express the degree of pain in numbers from 0-10, where 0 means no pain and 10 represents severe pain.
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 30 Jun 2021.
- 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.
Ahmed K Mohamed, MD study chair
Professor
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 and nerve stimulator in people with Shoulder and Upper Arm Injury, run by Minia 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 9 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 30 Jun 2021. 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?
Analgesic effect of each technique (time frame: 12 hour). 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 30 Jun 2021.