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Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01309360
Enrollment
120
Registered
2011-03-07
Start date
2009-09-30
Completion date
2010-04-30
Last updated
2011-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Surgical Procedures

Keywords

ultrasound, methaemoglobin, prilocaine, regional anesthesia, ASA risk groups I-II, adult outpatients, surgical spectrum covered procedures, distal forearm, hand

Brief 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 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.

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.

Interventions

DRUGmidazolam

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

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

Sponsors

Helios Research Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* severe coagulopathy * local or systemic inflammatory response * ASA-risk groups ≥ Grad III * severe anemia * heart failure * manifest shock * 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Complete Sensory Block60 minutes after administration of the local anestheticThe number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.
Number of Participants With Complete Motor BlocksWithin 60 minutes after administration of the local anestheticTo 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.
Onset Time.within 60 minutes after administration of the local anestheticTime from beginning of administration of the local anesthetic until complete sensoric block.

Secondary

MeasureTime frameDescription
Maximum Concentrations of Methemoglobin0,1,2,3,4 hours post-doseConcentration 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.
Number of Participants With Objective Adverse Events as a Measure of Safety and TolerabilityOutpatients were followed for the duration of hospital stay, an average of six hours.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.
Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.Outpatients were followed for the duration of hospital stay, an average of six hours.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.

Participant flow

Recruitment details

Provision of information and inclusion in the study was done in the anesthesia outpatients clinic as part of the standard preoperative preparation.

Pre-assignment details

Outpatients were prematurely dropped out for medical or non-medical reasons. Non-medical reasons:1.recall of the approval by the patient, 2.unavailability of the ultrasound-machine, 3.the planned operation was not carried out. Medical reasons: severe complications like systemic toxicity of the local anesthetic (seizure, cardiac arrest).

Participants by arm

ArmCount
Group A : 40ml Prilocaine 1%
40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
40
Group B : 30ml Prilocaine 1%
40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
40
Group C : 20ml Prilocaine 1%
40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
40
Total120

Baseline characteristics

CharacteristicGroup A : 40ml Prilocaine 1%Group B : 30ml Prilocaine 1%Group C : 20ml Prilocaine 1%Total
Age Continuous50 years
STANDARD_DEVIATION 14
47 years
STANDARD_DEVIATION 16
45 years
STANDARD_DEVIATION 16
47 years
STANDARD_DEVIATION 15
percentage of methemoglobin0.84 percentage of methemoglobin
STANDARD_DEVIATION 0.15
0.9 percentage of methemoglobin
STANDARD_DEVIATION 0.16
0.86 percentage of methemoglobin
STANDARD_DEVIATION 0.17
0.87 percentage of methemoglobin
STANDARD_DEVIATION 0.16
Sex: Female, Male
Female
23 Participants20 Participants24 Participants67 Participants
Sex: Female, Male
Male
17 Participants20 Participants16 Participants53 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
14 / 405 / 401 / 40
serious
Total, serious adverse events
0 / 400 / 400 / 40

Outcome results

Primary

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.

Time frame: Within 60 minutes after administration of the local anesthetic

Population: The analysis was per protocol.

ArmMeasureValue (NUMBER)
Group A : 40ml Prilocaine 1%Number of Participants With Complete Motor Blocks38 participants
Group B : 30ml Prilocaine 1%Number of Participants With Complete Motor Blocks36 participants
Group C : 20ml Prilocaine 1%Number of Participants With Complete Motor Blocks32 participants
p-value: 0.675Fisher Exact
p-value: 0.087Fisher Exact
p-value: 0.348Fisher Exact
Primary

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.

Time frame: 60 minutes after administration of the local anesthetic

Population: The analysis was per protocol.

ArmMeasureValue (NUMBER)
Group A : 40ml Prilocaine 1%Number of Participants With Complete Sensory Block38 participants
Group B : 30ml Prilocaine 1%Number of Participants With Complete Sensory Block39 participants
Group C : 20ml Prilocaine 1%Number of Participants With Complete Sensory Block39 participants
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Primary

Onset Time.

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

Time frame: within 60 minutes after administration of the local anesthetic

Population: In some cases the investigators were not able to exactly determine an onset time, so in cases of block failure (supplementation needed) or emergency situations outside this study (onset time not examined). Therefore the number of participants analyzed concerning onset time is lower then the total number of outpatients in each group.

ArmMeasureValue (MEAN)Dispersion
Group A : 40ml Prilocaine 1%Onset Time.18 minutesStandard Deviation 7
Group B : 30ml Prilocaine 1%Onset Time.20 minutesStandard Deviation 8
Group C : 20ml Prilocaine 1%Onset Time.26 minutesStandard Deviation 10
p-value: 0.247Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary

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.

Time frame: 0,1,2,3,4 hours post-dose

Population: Methemoglobin (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.The mean maximum Met-Hb was estimated in each group.

ArmMeasureValue (MEAN)Dispersion
Group A : 40ml Prilocaine 1%Maximum Concentrations of Methemoglobin4.7 percentage of methemoglobinStandard Deviation 2.1
Group B : 30ml Prilocaine 1%Maximum Concentrations of Methemoglobin3.7 percentage of methemoglobinStandard Deviation 1.3
Group C : 20ml Prilocaine 1%Maximum Concentrations of Methemoglobin2.4 percentage of methemoglobinStandard Deviation 0.7
p-value: 0Kruskal-Wallis
Secondary

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.

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

ArmMeasureValue (NUMBER)
Group A : 40ml Prilocaine 1%Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability13 participants
Group B : 30ml Prilocaine 1%Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability5 participants
Group C : 20ml Prilocaine 1%Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability1 participants
p-value: 0.059Fisher Exact
p-value: <0.001Fisher Exact
p-value: 0.2Fisher Exact
Secondary

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.

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

ArmMeasureValue (NUMBER)
Group A : 40ml Prilocaine 1%Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.4 participants
Group B : 30ml Prilocaine 1%Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.0 participants
Group C : 20ml Prilocaine 1%Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.0 participants
p-value: 0.116Fisher Exact
p-value: 0.116Fisher Exact
p-value: 1Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026