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

NCT ID: NCT01596998

Last Updated: 2012-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-04-30

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.

Conditions

Transversus Abdominis Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Levobupivacaine without epinephrine

Group Type: ACTIVE_COMPARATOR

Levobupivacaine without epinephrine

Intervention Type: DRUG

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.

Monitoring

Intervention Type: OTHER

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.

Determining the extent of the block

Intervention Type: OTHER

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.

Levobupivacaine with epinephrine

Group Type: EXPERIMENTAL

Levobupivacaine with epinephrine

Intervention Type: DRUG

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.

Monitoring

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy male volunteers
• ASA I-II

Exclusion Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Fernando Altermatt

Profesor Asistente, Departamento de Anestesiología

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando R Altermatt, MD

Role: PRINCIPAL_INVESTIGATOR

Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

Locations

Hospital Clinico Universidad Catolica

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

11-026

Identifier Type: -

Identifier Source: org_study_id