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

Phase 4

Completed

• Conditions: Transversus Abdominis Plane Block
• Interventions: Drug: Levobupivacaine without epinephrine; Drug: Levobupivacaine with epinephrine; Other: Monitoring; Other: Determining the extent of the block

• Registration Number: NCT01596998
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Last Update Submitted: 2012-05-10
• Study First Posted: 2012-05-11
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

• Healthy male volunteers
• ASA I-II

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levobupivacaine without epinephrine	Levobupivacaine without epinephrine	-
Levobupivacaine without epinephrine	Monitoring	-
Levobupivacaine without epinephrine	Determining the extent of the block	-
Levobupivacaine with epinephrine	Levobupivacaine with epinephrine	-
Levobupivacaine with epinephrine	Monitoring	-

Primary Outcome Measures

Name	Time	Method
Effect of the addition of vasoconstrictor in the plasma concentrations achieved	Since the beginning of the block up to 90 minutes after

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clinico Universidad Catolica; 🇨🇱 Santiago, Region Metropolitana, Chile