Other Surgical Procedures
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Sensory Block | 60 minutes after administration of the local anesthetic | 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. |
| Number of Participants With Complete Motor Blocks | Within 60 minutes after administration of the local anesthetic | 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. |
| Onset Time. | within 60 minutes after administration of the local anesthetic | Time from beginning of administration of the local anesthetic until complete sensoric block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentrations of Methemoglobin | 0,1,2,3,4 hours post-dose | 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. |
| Number of Participants With Objective 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 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
| Arm | Count |
|---|---|
| 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 |
| Total | 120 |
Baseline characteristics
| Characteristic | Group A : 40ml Prilocaine 1% | Group B : 30ml Prilocaine 1% | Group C : 20ml Prilocaine 1% | Total |
|---|---|---|---|---|
| Age Continuous | 50 years STANDARD_DEVIATION 14 | 47 years STANDARD_DEVIATION 16 | 45 years STANDARD_DEVIATION 16 | 47 years STANDARD_DEVIATION 15 |
| percentage of methemoglobin | 0.84 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 Participants | 20 Participants | 24 Participants | 67 Participants |
| Sex: Female, Male Male | 17 Participants | 20 Participants | 16 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 40 | 5 / 40 | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A : 40ml Prilocaine 1% | Number of Participants With Complete Motor Blocks | 38 participants |
| Group B : 30ml Prilocaine 1% | Number of Participants With Complete Motor Blocks | 36 participants |
| Group C : 20ml Prilocaine 1% | Number of Participants With Complete Motor Blocks | 32 participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A : 40ml Prilocaine 1% | Number of Participants With Complete Sensory Block | 38 participants |
| Group B : 30ml Prilocaine 1% | Number of Participants With Complete Sensory Block | 39 participants |
| Group C : 20ml Prilocaine 1% | Number of Participants With Complete Sensory Block | 39 participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A : 40ml Prilocaine 1% | Onset Time. | 18 minutes | Standard Deviation 7 |
| Group B : 30ml Prilocaine 1% | Onset Time. | 20 minutes | Standard Deviation 8 |
| Group C : 20ml Prilocaine 1% | Onset Time. | 26 minutes | Standard Deviation 10 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A : 40ml Prilocaine 1% | Maximum Concentrations of Methemoglobin | 4.7 percentage of methemoglobin | Standard Deviation 2.1 |
| Group B : 30ml Prilocaine 1% | Maximum Concentrations of Methemoglobin | 3.7 percentage of methemoglobin | Standard Deviation 1.3 |
| Group C : 20ml Prilocaine 1% | Maximum Concentrations of Methemoglobin | 2.4 percentage of methemoglobin | Standard Deviation 0.7 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A : 40ml Prilocaine 1% | Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability | 13 participants |
| Group B : 30ml Prilocaine 1% | Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability | 5 participants |
| Group C : 20ml Prilocaine 1% | Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability | 1 participants |
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.
| Arm | Measure | Value (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 |