Upper ExtremityPhase 4NCT00724035
Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
A Phase 4 study testing Midazolam, Ropivacaine and Fentanyl in people with Upper Extremity and Orthopedic Surgery, run by University of Parma at 1 site in Italy.
Trial summary
This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques. Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Extremity, Orthopedic Surgery, Trauma
- What is being tested?
- Midazolam, Ropivacaine and Fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- May 2008to Jul 2009
- 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
- ASA Physical Status Class <4
- Scheduled upper extremity orthopedic surgery
Who cannot join
- Psychiatric or cognitive disorder
- Allergy to study drugs
- Contraindication to nerve block at the assigned site
Trial locations and contacts
1 site in 1 country.
Italy1 site
University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, 43100
About this study
Official title: Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial
This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.
Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.
The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.
Read the detailed description
Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.
A reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.
The investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.
- Conditions
- Upper Extremity, Orthopedic Surgery, Trauma, Forearm Injuries, Nerve Block
- Being tested
- Midazolam, Ropivacaine, Fentanyl, General anesthesia, Axillary brachial plexus nerve block
- Keywords
- Anesthesia, Upper extremity, Nerve block, Ultrasound, Brachial plexus
- Medical subject headings
- Wounds and Injuries, Forearm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Versed, Benzodiazepine, Premedication, Sedation
Procedural sedation before the execution of the block.
- 0.03 mg/kg iv bolus
RopivacaineDrug
Also called Naropin, Local anesthetic, Amide local anesthetic
0.75% (wt/vol) solution, 20 ml perineural injection
FentanylDrug
Also called Opioid, Analgesic
50 µg iv bolus prn for pain during surgery, up to 150 µg
General anesthesiaProcedure or surgery
Also called Monitored anesthesia care
General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.
Axillary brachial plexus nerve blockProcedure or surgery
Also called Peripheral Nerve Block, Regional Anesthesia, Ultrasound
Blocks will be performed under high-resolution real-time ultrasound guidance.
Patients will be in the supine position. With the abducted arm flexed 90° at the elbow, the transducer will scan for the axillary artery in its short-axis. Individual nerves will be sought for around the artery.
A 22G, 17°-bevel needle will be advanced in-plane to inject aliquots of local anesthetic around each nerve structure up to the prescribed dose.
Infraclavicular brachial plexus blockProcedure or surgery
Also called Regional Anesthesia, Peripheral nerve block, Ultrasound
Blocks will be performed under high-resolution real-time ultrasound guidance.
Patients will be in the supine position. The linear transducer will be initially positioned between the middle and lateral third of the clavicle, scanning on a parasagittal plane.
The axillary artery and veins will then be sought for. We will try to visualize the three cords of the brachial plexus separately, and to inject local anesthetic around each of them. If this is not possible, the needle will be positioned cranially and posteriorly to the artery, and the injection will be made from there. A 20 G, 17°-bevel needle will be used for all blocks.
| Study group | Role | What they receive |
|---|---|---|
| Infraclavicular | Experimental | This group will receive an ultrasound-guided infraclavicular brachial plexus block. Receives: Drug: Midazolam; Drug: Ropivacaine; Drug: Fentanyl; Procedure: General anesthesia; Procedure: Infraclavicular brachial plexus block |
| Axillary | Active comparator | This group will receive an ultrasound-guided axillary brachial plexus block. Receives: Drug: Midazolam; Drug: Ropivacaine; Drug: Fentanyl; Procedure: General anesthesia; Procedure: Axillary brachial plexus nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of brachial plexus sensory block
Measured: q5min up to 30 min after the block
Secondary outcomes (4)
Onset of brachial plexus motor block
Measured: q5min up to 30 min after the block
Patient satisfaction (3-point scale)
Measured: End of surgery
Anesthesia-related procedural pain (0-10 numerical rating scale)
Measured: End of block placement
Rescue analgesic requirements during surgery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper ExtremityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Investigators
- Guido Fanelli, MD, Study chair, Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of ParmaGiorgio Danelli, MD, Principal investigator, UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724035
- Sponsor's protocol ID
- ANEST-ORT-02
- Status last verified
- Jul 2009
- First submitted
- 25 Jul 2008
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00724035
- Acronym / sponsor ID
- ANEST-ORT-02
- Conditions
- Upper Extremity, Orthopedic Surgery, Trauma, Forearm Injuries, Nerve Block
- Keywords
- Anesthesia, Upper extremity, Nerve block, Ultrasound, Brachial plexus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Jul 2008 (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.
This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.
Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.
The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.
Detailed description
Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.
A reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.
The investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infraclavicular | Experimental | Drug: Midazolam, Drug: Ropivacaine, Drug: Fentanyl, Procedure: General anesthesia, Procedure: Infraclavicular brachial plexus blockThis group will receive an ultrasound-guided infraclavicular brachial plexus block. |
| Axillary | Active comparator | Drug: Midazolam, Drug: Ropivacaine, Drug: Fentanyl, Procedure: General anesthesia, Procedure: Axillary brachial plexus nerve blockThis group will receive an ultrasound-guided axillary brachial plexus block. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA Physical Status Class <4
- Scheduled upper extremity orthopedic surgery
Key exclusion criteria (3 listed)
- Psychiatric or cognitive disorder
- Allergy to study drugs
- Contraindication to nerve block at the assigned site
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 |
|---|---|---|
| MidazolamAlso: Versed, Benzodiazepine, Premedication, SedationProcedural sedation before the execution of the block. * 0.03 mg/kg iv bolus | Drug | Axillary, Infraclavicular |
| RopivacaineAlso: Naropin, Local anesthetic, Amide local anesthetic0.75% (wt/vol) solution, 20 ml perineural injection | Drug | Axillary, Infraclavicular |
| FentanylAlso: Opioid, Analgesic50 µg iv bolus prn for pain during surgery, up to 150 µg | Drug | Axillary, Infraclavicular |
| General anesthesiaAlso: Monitored anesthesia careGeneral anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg. | Procedure or surgery | Axillary, Infraclavicular |
| Axillary brachial plexus nerve blockAlso: Peripheral Nerve Block, Regional Anesthesia, UltrasoundBlocks will be performed under high-resolution real-time ultrasound guidance. Patients will be in the supine position. With the abducted arm flexed 90° at the elbow, the transducer will scan for the axillary artery in its short-axis. Individual nerves will be sought for around the artery. A 22G, 17°-bevel needle will be advanced in-plane to inject aliquots of local anesthetic around each nerve structure up to the prescribed dose. | Procedure or surgery | Axillary |
| Infraclavicular brachial plexus blockAlso: Regional Anesthesia, Peripheral nerve block, UltrasoundBlocks will be performed under high-resolution real-time ultrasound guidance. Patients will be in the supine position. The linear transducer will be initially positioned between the middle and lateral third of the clavicle, scanning on a parasagittal plane. The axillary artery and veins will then be sought for. We will try to visualize the three cords of the brachial plexus separately, and to inject local anesthetic around each of them. If this is not possible, the needle will be positioned cranially and posteriorly to the artery, and the injection will be made from there. A 20 G, 17°-bevel needle will be used for all blocks. | Procedure or surgery | Infraclavicular |
Primary outcome
Onset time of brachial plexus sensory block
Time frame: q5min up to 30 min after the block
4 secondary outcomes
Onset of brachial plexus motor block
Time frame: q5min up to 30 min after the block
Patient satisfaction (3-point scale)
Time frame: End of surgery
Anesthesia-related procedural pain (0-10 numerical rating scale)
Time frame: End of block placement
Rescue analgesic requirements during surgery
Time frame: During 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 15 Jul 2009.
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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.
Guido Fanelli, MD study chair
Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma
Giorgio Danelli, MD principal investigator
UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma
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 Midazolam, Ropivacaine and Fentanyl in people with Upper Extremity and Orthopedic Surgery, run by University of Parma at 1 site in Italy.
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 2 inclusion and 3 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 15 Jul 2009. 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 Italy. 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?
Onset time of brachial plexus sensory block (time frame: q5min up to 30 min after the block). 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 15 Jul 2009.