Plasma Concentrations of Levobupivacaine With and Without Epinephrine in Transversus Abdominis Plane Blocks

PHASE4CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Transversus Abdominis Plane Block
Interventions
DRUG

Levobupivacaine with epinephrine

The subjects were randomized to receive a unilateral TAP block. This was realized using a sterile technique, guided by ultrasound. Two operators with experience in ultrasound-guided regional blocks performed all procedures. A high-resolution linear U.S. transducer (L38x/10-5 MHz Sonosite M-Turbo®, Bothell, WA) and a Stimuplex 100 mm needle, 20 gauge (B. Braun Stimuplex, Melgusen, Germany) were used. After obtaining a clear view of the blocking plane, between internal oblique and transverse muscles, 20 ml of levobupivacaine 0.25% with 5 µg/mL epinephrine were injected.

DRUG

Levobupivacaine without epinephrine

The subjects were randomized to receive a unilateral TAP block. This was realized using a sterile technique, guided by ultrasound. Two operators with experience in ultrasound-guided regional blocks performed all procedures. A high-resolution linear U.S. transducer (L38x/10-5 MHz, Sonosite M-Turbo ®, Bothell, WA) and a Stimuplex 100 mm needle, 20 gauge (B. Braun Stimuplex, Melgusen, Germany) were used. After obtaining a clear view of the blocking plane, between internal oblique and transverse muscles, 20 ml of levobupivacaine 0.25% were injected.

OTHER

Monitoring

Standard anesthetic monitoring was used, including continuous electrocardiogram, non invasive blood pressure and peripheral oxygen saturation. Later, under local anesthesia a permeable venous line and an arterial line were installed for blood sampling measures to determine local anesthetic plasma levels.

OTHER

Determining the extent of the block

The extent of sensory block was measured by assessment of temperature, soft and hard touch using alcohol, cotton and pin prick respectively. These measurements were made every 10 minutes during the first hour and every 30 minutes to complete 4 hours.

Trial Locations (1)

Unknown

Hospital Clinico Universidad Catolica, Santiago

All Listed Sponsors
lead

Pontificia Universidad Catolica de Chile

OTHER

NCT01596998 - Plasma Concentrations of Levobupivacaine With and Without Epinephrine in Transversus Abdominis Plane Blocks | Biotech Hunter | Biotech Hunter