Comparative study with prilocaine 1% and prilocaine 1.5% for ultrasound guided axillary brachial plexus blockade

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002744-14-BE

Enrollment

Unknown

Registered

2015-06-30

Start date

2015-12-23

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Tachipri Pharmaceutical Form: Solution for injection INN or Proposed INN: prilocaine CAS Number: 0000721-50-6 Other descriptive name: PRILOCAINE HYDROCHLORIDE Concentration unit: % percent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - gender: M/F - age: 18-70 years - indication for minor surgery of the hand or wrist Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - pregnancy or breastfeeding - contra-indications for locoregional anesthesia - neurologic disease - allergy or hypersensitivity to local anesthetics - known methemoglobinemia

Design outcomes

Primary

Measure	Time frame
Main Objective: In this study we will investigate the difference between prilocaine 1% and prilocaine 1.5% in relation to the time of onset of sensory and motor blockade and the quality and the duration of the block. In addition we will investigate if there is an effect of prilocaine in the used doses on the methemoglobinemia.;Secondary Objective: In addition we will investigate if there is an effect of prilocaine in the used doses on the methemoglobinemia.;Primary end point(s): 1. time to onset of sensory and motor block 2. quality of the block, represented by the need for additional analgesia or sedation perioperative 3. duration of the block: time to return of sensory and motor function ;Timepoint(s) of evaluation of this end point: 1. After performing the plexus block 2. During the surgical procedure 3. 24hrs postoperatively	—

Measure

Time frame

Main Objective: In this study we will investigate the difference between prilocaine 1% and prilocaine 1.5% in relation to the time of onset of sensory and motor blockade and the quality and the duration of the block. In addition we will investigate if there is an effect of prilocaine in the used doses on the methemoglobinemia.;Secondary Objective: In addition we will investigate if there is an effect of prilocaine in the used doses on the methemoglobinemia.;Primary end point(s): 1. time to onset of sensory and motor block 2. quality of the block, represented by the need for additional analgesia or sedation perioperative 3. duration of the block: time to return of sensory and motor function ;Timepoint(s) of evaluation of this end point: 1. After performing the plexus block 2. During the surgical procedure 3. 24hrs postoperatively

—

Secondary

Measure	Time frame
Secondary end point(s): methemoglobinemia;Timepoint(s) of evaluation of this end point: 30 minutes after the plexus block 1 hr after the plexus block	—

Countries

Belgium

Contacts

Public ContactData Nurse

Universitair Ziekenhuis Brussel

veerle.vanmossevelde@uzbrussel.be+3224763134

Outcome results