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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A : 40ml Prilocaine 1% | Active Comparator | 40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block |
|
| group B : 30ml Prilocaine 1% | Active Comparator | 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block |
|
| group C : 20ml Prilocaine 1% | Active Comparator | 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug | Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes after administration of the local anesthetic |
| 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. | Within 60 minutes after administration of the local anesthetic |
| Onset Time. | Time from beginning of administration of the local anesthetic until complete sensoric block. | within 60 minutes after administration of the local anesthetic |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0,1,2,3,4 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Seidel, Dr. med. | Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin | Principal Investigator |
| Georg Rehmert, Dr.med. | Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin | Study Director |
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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).
Provision of information and inclusion in the study was done in the anesthesia outpatients clinic as part of the standard preoperative preparation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A : 40ml Prilocaine 1% | 40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block |
| FG001 | Group B : 30ml Prilocaine 1% | 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block |
| FG002 | Group C : 20ml Prilocaine 1% | 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A : 40ml Prilocaine 1% | 40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block |
| BG001 | Group B : 30ml Prilocaine 1% | 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis was per protocol. | Posted | Number | participants | 60 minutes after administration of the local anesthetic |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A : 40ml Prilocaine 1% | 40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Systematic Assessment | Related to regional anesthesia when occuring during the peak of Met-Hb-formation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.med.Ronald Seidel | Helios-Kliniken Schwerin | 0049 (0)385 520-4251 | ronald.seidel@helios-kliniken.de |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| prilocaine 1% | Drug | 40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block |
|
|
| prilocaine 1% | Drug | 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block |
|
|
| prilocaine 1% | Drug | 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block |
|
|
| 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. | Outpatients were followed for the duration of hospital stay, an average of six hours. |
| 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. | Outpatients were followed for the duration of hospital stay, an average of six hours. |
| BG002 | Group C : 20ml Prilocaine 1% | 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| percentage of methemoglobin | Baseline levels of Met-Hb (percentage of methemoglobin) were measured using spectrophotometry prior to the anesthesia. | Mean | Standard Deviation | percentage of methemoglobin |
|
| OG002 | Group C : 20ml Prilocaine 1% | 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block |
|
|
|
| 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. | 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. | Posted | May 2011 | Mean | Standard Deviation | percentage of methemoglobin | 0,1,2,3,4 hours post-dose |
|
|
|
|
| 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. | Posted | Mar 2011 | Number | participants | Outpatients were followed for the duration of hospital stay, an average of six hours. |
|
|
|
|
| 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. | The analysis was per protocol. | Posted | Mar 2011 | Number | participants | Within 60 minutes after administration of the local anesthetic |
|
|
|
|
| Primary | Onset Time. | Time from beginning of administration of the local anesthetic until complete sensoric block. | 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. | Posted | Mar 2011 | Mean | Standard Deviation | minutes | within 60 minutes after administration of the local anesthetic |
|
|
|
|
| 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. | Posted | Mar 2011 | Number | participants | Outpatients were followed for the duration of hospital stay, an average of six hours. |
|
|
|
|
| 0 |
| 40 |
| 14 |
| 40 |
| EG001 | Group B : 30ml Prilocaine 1% | 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block | 0 | 40 | 5 | 40 |
| EG002 | Group C : 20ml Prilocaine 1% | 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block | 0 | 40 | 1 | 40 |
|
| headaches | Nervous system disorders | Systematic Assessment | Related to regional anesthesia when occuring during the peak of Met-Hb-formation. |
|
| objective signs of methemoglobinemia | Blood and lymphatic system disorders | As objective signs of increased concentration of methemoglobin we registrated lip cyanosis and/or drops in oxygen concentration measured with an standard two-wavelength-pulseoximeter. |
|
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| D006571 | Heterocyclic Compounds |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.2 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.348 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | <0.001 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 1 | 95 | No | Superiority or Other |