Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

NCT01309360 | Completed Phase 4 Results

• 1 other identifier: A 2009 24
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Other Surgical Procedures

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Maximum Concentrations of Methemoglobin

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

• 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.

• 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.

Study Arms (3)

group A : 40ml Prilocaine 1%

ACTIVE COMPARATOR

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

Drug: midazolam; Drug: prilocaine 1%

group B : 30ml Prilocaine 1%

ACTIVE COMPARATOR

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

Drug: midazolam; Drug: prilocaine 1%

group C : 20ml Prilocaine 1%

ACTIVE COMPARATOR

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

Drug: midazolam; Drug: prilocaine 1%

Interventions

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).

Also known as: Dormicum

group A : 40ml Prilocaine 1%; group B : 30ml Prilocaine 1%; group C : 20ml Prilocaine 1%

prilocaine 1% DRUG

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

Also known as: Xylonest 1%

group A : 40ml Prilocaine 1%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helios Research Center: lead

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr.med.Ronald Seidel
• Organization: Helios-Kliniken Schwerin

ronald.seidel@helios-kliniken.de

0049 (0)385 520-4251

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 7, 2011
• Study Start: September 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 12, 2011
• Results First Posted: June 27, 2011

Record last verified: 2011-06