NCT01596998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
Last Updated

May 11, 2012

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

May 9, 2012

Last Update Submit

May 10, 2012

Conditions

Transversus Abdominis Plane Block

Keywords

anesthesia, conductiontransversus abdominis plane blockVasoconstrictor AgentsUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Effect of the addition of vasoconstrictor in the plasma concentrations achieved

    Since the beginning of the block up to 90 minutes after

Secondary Outcomes (1)

  • 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

Study Arms (2)

Levobupivacaine without epinephrine

ACTIVE COMPARATOR
Drug: Levobupivacaine without epinephrineOther: MonitoringOther: Determining the extent of the block

Levobupivacaine with epinephrine

EXPERIMENTAL
Drug: Levobupivacaine with epinephrineOther: Monitoring

Interventions

Levobupivacaine with epinephrineDRUG

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.

Levobupivacaine with epinephrine
Levobupivacaine without epinephrineDRUG

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.

Levobupivacaine without epinephrine
MonitoringOTHER

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.

Levobupivacaine with epinephrineLevobupivacaine without epinephrine
Determining the extent of the blockOTHER

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 without epinephrine

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male volunteers
  • ASA I-II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universidad Catolica

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Interventions

LevobupivacaineEpinephrine

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Fernando R Altermatt, MD

    Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor Asistente, Departamento de Anestesiología

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 11, 2012

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 11, 2012

Record last verified: 2012-05

Locations

CL(1)