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

Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01596998
Enrollment
11
Registered
2012-05-11
Start date
2011-12-31
Completion date
2012-04-30
Last updated
2012-05-11

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

Conditions

Transversus Abdominis Plane Block

Keywords

anesthesia, conduction, transversus abdominis plane block, Vasoconstrictor Agents, Ultrasonography

Brief summary

The aim of this study is to determine the effect of the addition of vasoconstrictor in the plasma concentrations achieved and the extent of the transversus abdominis plane block in healthy male volunteers.

Detailed description

Use of TAP blocks, decreases use of opioids and reduces pain scores during the postoperative period after surgeries involving the anterior abdominal wall. However, the information regarding the sensitive range of the blockade and its duration is still limited. Since that the area of administration is an intermuscular plane, it is possible to infer a large area of absorption. Knowing plasma concentrations is essential to balance the usefulness of this technique with potential systemic toxicity associated with its use. As an additional effect, clinically, the use of vasoconstrictors may prolong the duration of the blockade significantly, depending on the drug used and site of administration. To date, no studies evaluating the effect of the addition of vasoconstrictor both in the plasma concentrations achieved, and the quality, extent and duration of the TAP block.

Interventions

DRUGLevobupivacaine 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.

DRUGLevobupivacaine 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.

OTHERMonitoring

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.

OTHERDetermining 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.

Sponsors

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Healthy volunteers
Yes

Inclusion criteria

* Healthy male volunteers * ASA I-II

Exclusion criteria

* BMI \> 30kg m-2 * Patients with allergy to study drugs

Design outcomes

Primary

MeasureTime frame
Effect of the addition of vasoconstrictor in the plasma concentrations achievedSince the beginning of the block up to 90 minutes after

Secondary

MeasureTime frame
Determine the mapping of sensory block in the abdominal wall after the completion of a U.S. guided TAP Block in healthy volunteers.Since the beginning of the block up to 4 hours after

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026