Phase 4 N=120 Single-blind Treatment

Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

Other Surgical Procedures

Bottom Line

View on ClinicalTrials.gov: NCT01309360 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Number of Participants With Complete Sensory Block — 38; 39; 39 participants — p=1

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: midazolam (Drug); prilocaine 1% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Helios Research Center
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Sensory Block	38; 39; 39	1
PRIMARY Number of Participants With Complete Motor Blocks	38; 36; 32	0.675
PRIMARY Onset Time.	18; 20; 26	0.247
SECONDARY Maximum Concentrations of Methemoglobin	4.7; 3.7; 2.4	—
SECONDARY Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability	13; 5; 1	0.059
SECONDARY Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.	4; 0; 0	0.116

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.

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

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Data sourced from ClinicalTrials.gov (NCT01309360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.