Orthopaedic DisordersPhase 4NCT01989312
The Simultaneous Use of Supraclavicular and Distal Blocks
A Phase 4 study testing intravenous cannulation., Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks. and Routine ASA monitoring in people with Orthopaedic Disorders and Nerve Block, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopaedic Disorders, Nerve Block, Anaesthesia
- What is being tested?
- intravenous cannulation., Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks. and Routine ASA monitoring
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2012to Feb 2013
- Phase
- Phase 4
- 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
- 18 and 80 years old patient
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective hand and forearm surgery
Who cannot join
- patient refusal
- preexisting neuropathy
- coagulopathy
- allergy to agents used
- pregnancy
- body mass index > 35 kg/m2
Show all 9Show fewer
- chronic obstructive pulmonary disease
- infection or previous surgery in the supraclavicular area
- systemic infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab
Ankara, 06700
About this study
Official title: Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study
The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block alone.
Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5 minutes starting at the 10th minutes. The imaging, needling and performance times will be recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic time will be noted.
- Conditions
- Orthopaedic Disorders, Nerve Block, Anaesthesia
- Being tested
- intravenous cannulation., Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks., Routine ASA monitoring, Premedication midazolam, Lidocaine
- Keywords
- ultrasound, peripheral nerves, anesthetics, local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous cannulation.Procedure or surgery
A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site
Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.Procedure or surgery
Supraclavicular block with 20 mL of lidocaine 1.5% + epinephrine 5µg/mL and the addition of ultrasound-guided ulnar, median and radial nerve blocks. For that 12 mL of local anesthetic solution of a 50:50 mixture of lidocaine 2% and levobupivacaine 0.5% (4 mL/nerve) was used.
Intravenous cannulation.Device
A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site
Routine ASA monitoringDevice
Monitorization with ECG, noninvasive blood pressure and spO2.
Premedication midazolamDrug
Premedication with 0.03 mg/kg midazolam iv
LidocaineDrug
EpinephrineDrug
LevobupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| supraclavicular block | Active comparator | A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand. Receives: Procedure: intravenous cannulation.; Device: Intravenous cannulation.; Device: Routine ASA monitoring; Drug: Premedication midazolam; Drug: Lidocaine; Drug: Epinephrine |
| Supraclavicular and median, ulnar, radial blocks | Active comparator | Patients in this group received 20 mL of lidocaine 1.5% + epinephrine 5µg/mL for supraclavicular block and after the supraclavicular block they recieved a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Receives: Procedure: Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.; Device: Intravenous cannulation.; Device: Routine ASA monitoring; Drug: Premedication midazolam; Drug: Lidocaine; Drug: Epinephrine; Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required after a supraclavicular block alone or a supraclavicular block combined with distal blocks, to achieve a sensory and motor block needed for surgery.
The onset time of supraclavicular plexus block and the onset time of supraclavicular block combined with distal median, radial, and ulnar nerve blocks will be followed up. The time needed to achieve a surgical block will be assessed in both groups. The difference between the 2 groups will be compared and analysed. For this an investigator blinded to the group allocation will evaluate the sensorial pinprick and motor blocks of the ulnar, median, radial and musculocutaneous nerves every 5 minutes starting at the 10th minutes until 30th minutes.
Measured: All patients will be followed up during the block procedure and during the surgery. Also, after the surgery patients will be followed up to 7 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic DisordersStudies of the same condition, open and under way.
- More trials run by Ankara 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Ceyda MECO, Ankara University
- Investigators
- Basak Ceyda Meco, MD, DESA, Principal investigator, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989312
- Sponsor's protocol ID
- 03-99-12
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01989312
- Acronym / sponsor ID
- 03-99-12
- Conditions
- Orthopaedic Disorders, Nerve Block, Anaesthesia
- Keywords
- ultrasound, peripheral nerves, anesthetics, local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Nov 2013 (estimated)
- 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 aim of this study is to compare the combined ultrasound-guided supraclavicular brachial plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block alone.
Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5 minutes starting at the 10th minutes. The imaging, needling and performance times will be recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic time will be noted.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraclavicular block | Active comparator | Procedure: intravenous cannulation., Device: Intravenous cannulation., Device: Routine ASA monitoring, Drug: Premedication midazolam, Drug: Lidocaine, Drug: EpinephrineA supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand. |
| Supraclavicular and median, ulnar, radial blocks | Active comparator | Procedure: Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks., Device: Intravenous cannulation., Device: Routine ASA monitoring, Drug: Premedication midazolam, Drug: Lidocaine, Drug: Epinephrine, Drug: LevobupivacainePatients in this group received 20 mL of lidocaine 1.5% + epinephrine 5µg/mL for supraclavicular block and after the supraclavicular block they recieved a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 and 80 years old patient
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective hand and forearm surgery
Key exclusion criteria (9 listed)
- patient refusal
- preexisting neuropathy
- coagulopathy
- allergy to agents used
- pregnancy
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 |
|---|---|---|
| intravenous cannulation.A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site | Procedure or surgery | supraclavicular block |
| Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.Supraclavicular block with 20 mL of lidocaine 1.5% + epinephrine 5µg/mL and the addition of ultrasound-guided ulnar, median and radial nerve blocks. For that 12 mL of local anesthetic solution of a 50:50 mixture of lidocaine 2% and levobupivacaine 0.5% (4 mL/nerve) was used. | Procedure or surgery | Supraclavicular and median, ulnar, radial blocks |
| Intravenous cannulation.A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site | Device | Supraclavicular and median, ulnar, radial blocks, supraclavicular block |
| Routine ASA monitoringMonitorization with ECG, noninvasive blood pressure and spO2. | Device | Supraclavicular and median, ulnar, radial blocks, supraclavicular block |
| Premedication midazolamPremedication with 0.03 mg/kg midazolam iv | Drug | Supraclavicular and median, ulnar, radial blocks, supraclavicular block |
| Lidocaine | Drug | Supraclavicular and median, ulnar, radial blocks, supraclavicular block |
| Epinephrine | Drug | Supraclavicular and median, ulnar, radial blocks, supraclavicular block |
| Levobupivacaine | Drug | Supraclavicular and median, ulnar, radial blocks |
Primary outcome
The time required after a supraclavicular block alone or a supraclavicular block combined with distal blocks, to achieve a sensory and motor block needed for surgery.
Time frame: All patients will be followed up during the block procedure and during the surgery. Also, after the surgery patients will be followed up to 7 days postoperatively.
The onset time of supraclavicular plexus block and the onset time of supraclavicular block combined with distal median, radial, and ulnar nerve blocks will be followed up. The time needed to achieve a surgical block will be assessed in both groups. The difference between the 2 groups will be compared and analysed. For this an investigator blinded to the group allocation will evaluate the sensorial pinprick and motor blocks of the ulnar, median, radial and musculocutaneous nerves every 5 minutes starting at the 10th minutes until 30th 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 21 Nov 2013.
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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.
Basak Ceyda Meco, MD, DESA principal investigator
Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous cannulation., Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks. and Routine ASA monitoring in people with Orthopaedic Disorders and Nerve Block, run by Ankara University 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 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 21 Nov 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 time required after a supraclavicular block alone or a supraclavicular block combined with distal blocks, to achieve a sensory and motor block needed for surgery. (time frame: All patients will be followed up during the block procedure and during the surgery. Also, after the surgery patients will be followed up to 7 days 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 21 Nov 2013.