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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fernando Altermatt, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01596998
First received: May 9, 2012
Last updated: May 10, 2012
Last verified: May 2012

May 9, 2012
May 10, 2012
December 2011
April 2012   (final data collection date for primary outcome measure)
Effect of the addition of vasoconstrictor in the plasma concentrations achieved [ Time Frame: Since the beginning of the block up to 90 minutes after ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01596998 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Transversus Abdominis Plane Block
  • 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.
  • Active Comparator: Levobupivacaine without epinephrine
    Interventions:
    • Drug: Levobupivacaine without epinephrine
    • Other: Monitoring
    • Other: Determining the extent of the block
  • Experimental: Levobupivacaine with epinephrine
    Interventions:
    • Drug: Levobupivacaine with epinephrine
    • Other: Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers
  • ASA I-II

Exclusion Criteria:

  • BMI > 30kg m-2
  • Patients with allergy to study drugs
Male
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT01596998
11-026
No
Fernando Altermatt, Pontificia Universidad Catolica de Chile
Pontificia Universidad Catolica de Chile
Not Provided
Principal Investigator: Fernando R Altermatt, MD Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
Pontificia Universidad Catolica de Chile
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP