PATIENTS WITH UPPER EXTREMITY SURGERYNCT05706090
Effect of Neurostimulator Usage on Block Success
A study testing fentanyl will be added and general anesthesia in people with PATIENTS WITH UPPER EXTREMITY SURGERY, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The need of a neurostimulator for a successful nerve block was questioned in different block types after ultrasound has become standard. The aim of this clinical study was to determine the effect of neurostimulator use on block success in costoclavicular block Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PATIENTS WITH UPPER EXTREMITY SURGERY
- What is being tested?
- fentanyl will be added and general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 2 Jan 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Class I, II and III of American Society of Anesthesiologists (ASA) classification
- being between 18 and 80 years of age,
- body mass index (BMI) between 18 and 35 kg/m2
Who cannot join
- Patients who did not give consent,
- were above ASA III,
- pregnant,
- had a neuromuscular disease,
- bleeding diathesis,
- a local anesthetic allergy,
- an infection in the area where nerve block would be applied, and
- had previously operated from the infraclavicular fossa were not included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazoosmanpasa Education and Research Hospital
Istanbul
About this study
Official title: Effect of Neurostimulator Usage on Block Success in Costoclavicular Block: a Randomized Controlled Trial
The need of a neurostimulator for a successful nerve block was questioned in different block types after ultrasound has become standard. The aim of this clinical study was to determine the effect of neurostimulator use on block success in costoclavicular block
- Conditions
- PATIENTS WITH UPPER EXTREMITY SURGERY
- Being tested
- fentanyl will be added, general anesthesia
- Keywords
- Brachial Plexus Block; Nerve Block; Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl will be addedDrug
If adequate anagesia is not provided with the block, 1 microgram/kg of fentanyl will be added
general anesthesiaProcedure or surgery
If adequate anagesia is not provided with the block, general anesthesia will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group USP | Experimental | The group using ultrasound and injection pressure manometer was named USP Receives: Drug: fentanyl will be added; Procedure: general anesthesia |
| Group USPN | Experimental | The group using ultrasound , injection pressure manometer , and neurostimulator was named USPN Receives: Drug: fentanyl will be added; Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The block success rate (ratio of successful blocks to all blocks)
The block was considered unsuccessful in case of analgesic need during the surgery or transition to general anesthesia, otherwise, these patients were included in the successful block group.
Measured: during procedure
Secondary outcomes (3)
Block application time
THE TIME BETWEEN THE NEEDLE ENTRY THROUGH THE SKIN AND THE OUTPUT OF THE NEEDLE AFTER LOCAL ANESTHETICS IS GIVEN, WAS RECORDED AS THE APPLICATION TIME
Measured: 30 minutes
time to readiness for surgery
Sensory and motor block levels were evaluated in the median, radial, ulnar and musculocutaneous nerve traces at 5-minute intervals for 30 minutes. An ice pack was used for sensory block evaluation. It was scored as follows; 0: completely felt; 1: has a sense of touch; no cold; 2: no sense of touch. Lateral surface of the forearm for the musculocutaneous nerve, the surface of the thumb facing the palm for the median nerve, the inner surface of the 5th finger for the ulnar nerve, and the posterior surface of the hand for the radial nerve were used for sensorial evaluation. Motor block was scored as follows; 0: full motion; 1: paresis; 2: complete block. Elbow flexion for the musculocutaneous nerve, thumb opposition for the median nerve, 5th finger abduction for the ulnar nerve, and wrist extension for the radial nerve were used to evaluate motor block. The block was considered successful if the total score was 14 or higher, with a total sensory score of at least 7.
Measured: 30 minutes
number of needle passes
. The number of needle passes was calculated by adding each needle advancement exceeding 10 mm to the first needle insertion.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Feb 2020
- Primary completion1 Feb 2020
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PATIENTS WITH UPPER EXTREMITY SURGERYStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706090
- Sponsor's protocol ID
- Neurostimulator Usage
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 31 Jan 2023
- 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 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurostimulator Usage on Block Success in Costoclavicular Block: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05706090
- Acronym / sponsor ID
- Neurostimulator Usage
- Conditions
- PATIENTS WITH UPPER EXTREMITY SURGERY
- Keywords
- Brachial Plexus Block; Nerve Block; Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 31 Jan 2023 (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 need of a neurostimulator for a successful nerve block was questioned in different block types after ultrasound has become standard. The aim of this clinical study was to determine the effect of neurostimulator use on block success in costoclavicular block
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group USP | Experimental | Drug: fentanyl will be added, Procedure: general anesthesiaThe group using ultrasound and injection pressure manometer was named USP |
| Group USPN | Experimental | Drug: fentanyl will be added, Procedure: general anesthesiaThe group using ultrasound , injection pressure manometer , and neurostimulator was named USPN |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Class I, II and III of American Society of Anesthesiologists (ASA) classification
- being between 18 and 80 years of age,
- body mass index (BMI) between 18 and 35 kg/m2
Key exclusion criteria (8 listed)
- Patients who did not give consent,
- were above ASA III,
- pregnant,
- had a neuromuscular disease,
- bleeding diathesis,
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 |
|---|---|---|
| fentanyl will be addedIf adequate anagesia is not provided with the block, 1 microgram/kg of fentanyl will be added | Drug | Group USP, Group USPN |
| general anesthesiaIf adequate anagesia is not provided with the block, general anesthesia will be administered. | Procedure or surgery | Group USP, Group USPN |
Primary outcome
The block success rate (ratio of successful blocks to all blocks)
Time frame: during procedure
The block was considered unsuccessful in case of analgesic need during the surgery or transition to general anesthesia, otherwise, these patients were included in the successful block group.
3 secondary outcomes
Block application time
Time frame: 30 minutes
time to readiness for surgery
Time frame: 30 minutes
number of needle passes
Time frame: 30 minutes
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 31 Jan 2023.
- 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 fentanyl will be added and general anesthesia in people with PATIENTS WITH UPPER EXTREMITY SURGERY, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 31 Jan 2023. 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 Turkey (Türkiye). 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?
The block success rate (ratio of successful blocks to all blocks) (time frame: during procedure). 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 31 Jan 2023.