Plasma Concentrations of Levobupivacaine With and Without Epinephrine in Transversus Abdominis Plane Blocks - Full Text View

Purpose

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.

Condition	Intervention	Phase
Transversus Abdominis Plane Block	Drug: Levobupivacaine with epinephrine Drug: Levobupivacaine without epinephrine Other: Monitoring Other: Determining the extent of the block	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Official Title:	Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound.

Resource links provided by NLM:

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	11
Study Start Date:	December 2011
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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. 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.

Arms

Assigned Interventions

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

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.

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.

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male volunteers
ASA I-II

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596998

Locations

Chile
Hospital Clinico Universidad Catolica
Santiago, Region Metropolitana, Chile

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile

Investigators

Principal Investigator:

Fernando R Altermatt, MD

Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

More Information

No publications provided

Responsible Party:	Fernando Altermatt, Profesor Asistente, Departamento de Anestesiología, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:	NCT01596998 History of Changes
Other Study ID Numbers:	11-026
Study First Received:	May 9, 2012
Last Updated:	May 10, 2012
Health Authority:	Chile: Institutional Review Board

Keywords provided by Pontificia Universidad Catolica de Chile:

anesthesia, conduction
transversus abdominis plane block
Vasoconstrictor Agents
Ultrasonography

Additional relevant MeSH terms:

Epinephrine
Epinephryl borate
Vasoconstrictor Agents
Levobupivacaine
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013