Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

NCT ID: NCT01309360

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-04-30

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.

Conditions

Other Surgical Procedures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A : 40ml Prilocaine 1%

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

Group Type: ACTIVE_COMPARATOR

midazolam

Intervention Type: DRUG

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%

Intervention Type: DRUG

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

group B : 30ml Prilocaine 1%

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

Group Type: ACTIVE_COMPARATOR

midazolam

Intervention Type: DRUG

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%

Intervention Type: DRUG

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

group C : 20ml Prilocaine 1%

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

Group Type: ACTIVE_COMPARATOR

midazolam

Intervention Type: DRUG

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%

Intervention Type: DRUG

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

Interventions

midazolam

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

Intervention Type: DRUG

prilocaine 1%

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

Intervention Type: DRUG

prilocaine 1%

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

Intervention Type: DRUG

prilocaine 1%

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

Intervention Type: DRUG

Other Intervention Names

Dormicum; Xylonest 1%; Xylonest 1%; Xylonest 1%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helios Research Center

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

Principal Investigators

Ronald Seidel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

Georg Rehmert, Dr.med.

Role: STUDY_DIRECTOR

Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

Other Identifiers

A 2009 24

Identifier Type: -

Identifier Source: org_study_id