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Other Surgical ProceduresPhase 4NCT01309360

Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

A Phase 4 study testing midazolam and prilocaine 1% in people with Other Surgical Procedures, run by Helios Research Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus anesthesia have any effect on the success rate and additional parameters of block quality? Methodology: In this prospective cohort study three groups of 40 outpatients each were administered dosages of 1% prilocaine of either… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Other Surgical Procedures
What is being tested?
midazolam and prilocaine 1%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Sep 2009to Apr 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • elective surgery on the distal forearm or the hand
  • adult outpatients, age 18-75 years old
  • ASA-risk groups I-II (American Society of Anesthesiologists)
  • Body Mass Index 17-35
  • informed consent

Who cannot join

  • severe coagulopathy
  • local or systemic inflammatory response
  • ASA-risk groups ≥ Grad III
  • severe anemia
  • heart failure
  • manifest shock
Show all 14Show fewer
  • other drugs with influence on methaemoglobinemia (nitrates, sulfonamides etc.)
  • domestic care after surgery not ensured
  • drug allergy : local anesthetics
  • severe polyneuropathy
  • pregnancy, lactation period
  • participation in other studies
  • non-cooperative patients
  • addiction to drugs or alcohol

About this study

Official title: Ultrasound-guided Block of the Brachial Plexus Using Prilocaine: Effects of Local-anesthetic Dose Reduction on Parameters of Block Quality and Adverse Effects in Outpatients

Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus anesthesia have any effect on the success rate and additional parameters of block quality? Methodology: In this prospective cohort study three groups of 40 outpatients each were administered dosages of 1% prilocaine of either 40mL, 30mL or 20mL for axillary plexus anesthesia. Met-Hb was measured prior to administration of the block and then hourly until the Met-Hb concentration fell. Parameters of block quality and any adverse effects were recorded. The level of significance was defined with α ≤ 0.05.

Read the detailed description

Background

With the availability of high resolution portable ultrasound equipment, the use of sonography in the field of anesthesia has become more widespread in recent years. The investigators would like to draw attention to a meta-analysis of prospective randomized studies by Abrahams et al. as being representative of the numerous publications available. Compared to nerve stimulation, ultrasound-guided nerve blocks have a higher success rate with significantly fewer vascular punctures and shorter procedure times. However, the administration of ultrasound-guided regional anesthesia necessitates considerable equipment acquisition and training expenses. Nevertheless, the suggested benefits resulting from savings in time and local anesthetic, increased patient satisfaction and avoidance of complications should be considered in addition to the results from Abrahams et al.

The aim of the present work was to investigate whether an ultrasound-guided block combined with a reduced dose of the local anesthetic prilocaine altered the success rate or other parameters of block quality. Any adverse effects and the methaemoglobin concentration were also recorded.

Methodology

After receiving ethics committee approval and after informing patients, ultrasound-guided axillary plexus anesthesia was carried out on 120 adult outpatients in ASA risk groups I-II. The surgical spectrum covered procedures on the distal forearm or the hand (carpal tunnel syndrome, ganglion extirpation, removal of material, etc.). Provision of information and inclusion in the study was done in the anesthesia outpatients' clinic as part of the standard preoperative preparation. Prior to administering the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg). Application of the local anesthesia was done prospectively and single blind in 3 cohorts with decreasing dosage. The patients received either 400mg (group A), 300mg (group B) or 200mg (group C) of prilocaine 1%. The block was performed under sterile conditions using a portable ultrasound device (Sonosite S-Nerve) and a 24 G short bevel cannula with flexible tubing. The block was performed using combined out-of-plane (n. musculocutaneous) and in-plane techniques (n.radialis, n.medianus, n.ulnaris), usually from a single puncture site. The outpatients were cared for in the anesthesia care unit preoperatively and postoperatively until their discharge. NIBP, pulse oxymetry and ECG were continuously monitored. The discharge criteria were widespread regression of the block with a subjective feeling of well-being including adequate analgesia and stable vital signs with methemoglobin (Met-Hb) concentrations ≤ 5%. Met-Hb levels were measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. A complete sensory block of all 4 nerves within 60 minutes of administration of the local anesthetic was rated as a successful block.

For the statistical analysis the investigators selected distribution-free, nonparametric test methods. The Mann-Whitney U test was used when comparing 2 groups and the Kruskal-Wallis test or Fisher's exact test was used when comparing more than 2 groups. The level of significance was defined with α ≤ 0.05. With multiple paired comparisons the significance level was adjusted using the Bonferroni correction. The Bravais-Pearson correlation coefficient rho describes the relationship between the maximum Met-Hb value and the weight-based prilocaine dose in mg/kg.

Being tested
midazolam, prilocaine 1%
Keywords
ultrasound, methaemoglobin, prilocaine, regional anesthesia, ASA risk groups I-II, adult outpatients, surgical spectrum covered procedures, distal forearm, hand

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • midazolamDrug

    Also called Dormicum

    Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).

  • prilocaine 1%Drug

    Also called Xylonest 1%

    40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block

  • prilocaine 1%Drug

    Also called Xylonest 1%

    40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block

  • prilocaine 1%Drug

    Also called Xylonest 1%

    40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block

Study groups in NCT01309360
Study groupRoleWhat they receive
group A : 40ml Prilocaine 1%Active comparator40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
Receives: Drug: midazolam; Drug: prilocaine 1%
group B : 30ml Prilocaine 1%Active comparator40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
Receives: Drug: midazolam; Drug: prilocaine 1%
group C : 20ml Prilocaine 1%Active comparator40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
Receives: Drug: midazolam; Drug: prilocaine 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Complete Sensory Block

    The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.

    Measured: 60 minutes after administration of the local anesthetic

  2. Number of Participants With Complete Motor Blocks

    To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic.

    Measured: Within 60 minutes after administration of the local anesthetic

  3. Onset Time.

    Time from beginning of administration of the local anesthetic until complete sensoric block.

    Measured: within 60 minutes after administration of the local anesthetic

Secondary outcomes (3)
  1. Maximum Concentrations of Methemoglobin

    Concentration of Methemoglobin (Met-Hb) was measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. The maximum amount was reached in every case two or three hours after administration of the local anesthetic.

    Measured: 0,1,2,3,4 hours post-dose

  2. Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability

    In groups A, B and C was determined the rate of objective clinical signs of increased Met-Hb-levels : drops in oxygen saturation <93% using pulseoximetry or lip cyanosis.

    Measured: Outpatients were followed for the duration of hospital stay, an average of six hours.

  3. Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.

    In groups A, B and C was determined the rate of subjective clinical signs of increased Met-Hb-Levels : headaches or dizziness, when correlated with the peak-Met-Hb-Level.

    Measured: Outpatients were followed for the duration of hospital stay, an average of six hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2011 (estimated)
  2. Study startSep 2009
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309360
Sponsor's protocol ID
A 2009 24
Status last verified
Jun 2011
First submitted
4 Mar 2011
Last updated
12 Jul 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing midazolam and prilocaine 1% in people with Other Surgical Procedures, run by Helios Research Center.

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 5 inclusion and 14 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 27 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Complete Sensory Block (time frame: 60 minutes after administration of the local anesthetic). The study lists 3 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 12 Jul 2011.

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