Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

This study has been completed.
Sponsor:
Information provided by:
Helios Research Center
ClinicalTrials.gov Identifier:
NCT01309360
First received: March 4, 2011
Last updated: July 6, 2011
Last verified: June 2011
Results First Received: May 4, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Other Surgical Procedures
Interventions: Drug: midazolam
Drug: prilocaine 1%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Group A : 40ml Prilocaine 1% 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 C : 20ml Prilocaine 1% 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block

Participant Flow:   Overall Study
    Group A : 40ml Prilocaine 1%     Group B : 30ml Prilocaine 1%     Group C : 20ml Prilocaine 1%  
STARTED     40     40     40  
COMPLETED     40     40     40  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group A : 40ml Prilocaine 1% 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 C : 20ml Prilocaine 1% 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
Total Total of all reporting groups

Baseline Measures
    Group A : 40ml Prilocaine 1%     Group B : 30ml Prilocaine 1%     Group C : 20ml Prilocaine 1%     Total  
Number of Participants  
[units: participants]
  40     40     40     120  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 14     47  ± 16     45  ± 16     47  ± 15  
Gender  
[units: participants]
       
Female     23     20     24     67  
Male     17     20     16     53  
percentage of methemoglobin [1]
[units: percentage¬†of¬†methemoglobin]
Mean ± Standard Deviation
  0.84  ± 0.15     0.9  ± 0.16     0.86  ± 0.17     0.87  ± 0.16  
[1] Baseline levels of Met-Hb (percentage of methemoglobin) were measured using spectrophotometry prior to the anesthesia.



  Outcome Measures
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1.  Primary:   Number of Participants With Complete Sensory Block   [ Time Frame: 60 minutes after administration of the local anesthetic ]

2.  Primary:   Number of Participants With Complete Motor Blocks   [ Time Frame: Within 60 minutes after administration of the local anesthetic ]

3.  Primary:   Onset Time.   [ Time Frame: within 60 minutes after administration of the local anesthetic ]

4.  Secondary:   Maximum Concentrations of Methemoglobin   [ Time Frame: 0,1,2,3,4 hours post-dose ]

5.  Secondary:   Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Outpatients were followed for the duration of hospital stay, an average of six hours. ]

6.  Secondary:   Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.   [ Time Frame: Outpatients were followed for the duration of hospital stay, an average of six hours. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr.med.Ronald Seidel
Organization: Helios-Kliniken Schwerin
phone: 0049 (0)385 520-4251
e-mail: ronald.seidel@helios-kliniken.de


No publications provided


Responsible Party: Dr.med. Ronald Seidel, Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
ClinicalTrials.gov Identifier: NCT01309360     History of Changes
Other Study ID Numbers: A 2009 24
Study First Received: March 4, 2011
Results First Received: May 4, 2011
Last Updated: July 6, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices