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

May 10, 2012 updated by: Fernando Altermatt, Pontificia Universidad Catolica de Chile

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Hospital Clinico Universidad Catolica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers
  • ASA I-II

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levobupivacaine without epinephrine
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.
Experimental: Levobupivacaine with epinephrine
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of the addition of vasoconstrictor in the plasma concentrations achieved
Time Frame: Since the beginning of the block up to 90 minutes after
Since the beginning of the block up to 90 minutes after

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the mapping of sensory block in the abdominal wall after the completion of a U.S. guided TAP Block in healthy volunteers.
Time Frame: Since the beginning of the block up to 4 hours after
Since the beginning of the block up to 4 hours after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Fernando R Altermatt, MD, Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 11, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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