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

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 4

Conditions: Transversus Abdominis Plane Block

Treatments: Other: Monitoring; Drug: Levobupivacaine with epinephrine; Other: Determining the extent of the block; Drug: Levobupivacaine without epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01596998

11-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers
• ASA I-II

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Levobupivacaine without epinephrine

Active Comparator group

Treatment:

Other: Monitoring

Other: Determining the extent of the block

Drug: Levobupivacaine without epinephrine

Levobupivacaine with epinephrine

Experimental group

Treatment:

Other: Monitoring

Drug: Levobupivacaine with epinephrine