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Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift

NCT ID: NCT01669018

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

Brief Summary

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Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a relevant technique in patients with severe cardiac comorbidity. The technique is a safer alternative compared to general or spinal anesthesia in these fragile patients.

The most recognized technique with ultrasound guidance (Karmakars technique) is technically demanding and based on injection of local anesthetic relatively close to the exit of the spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal prompting a risk of low blood pressure. This may be fatal in high risk patients.

The investigators have developed a simple technique based on injection away from the spinal canal. The investigators expect minimal risk of spread of local anesthetic to the spinal canal with this technique.

This randomized, double blinded trial compares the new technique to the established technique of ultrasound guided blockade of the lumbar plexus.

The hypothesis is that the new technique has a higher success rate with reduced effect on blood pressure for ultrasound guided lumbar plexus block compared to the established technique.

Detailed Description

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Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Lumbar ultrasound trident (LUT)

Lumbar plexus block using LUT technique

Group Type ACTIVE_COMPARATOR

Lumbar plexus block using LUT technique

Intervention Type PROCEDURE

Lumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced.

Supra Sacral Parallel Shift (SSPS)

Lumbar plexus block using SSPS technique

Group Type EXPERIMENTAL

Lumbar plexus block using SSPS technique

Intervention Type PROCEDURE

Lumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced.

Interventions

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Lumbar plexus block using LUT technique

Lumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced.

Intervention Type PROCEDURE

Lumbar plexus block using SSPS technique

Lumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* ASA I (American Society of Anesthesiologists physical status classification)

Exclusion Criteria

* volunteers who are not able to cooperate
* volunteers who do not understand and speak danish
* daily use of analgesics
* allergy to local analgesics or contrast agents
* abuse of medicine or alcohol
* volunteers with technical impediments of the planned interventions
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Thomas F. Bendtsen

Consultant anesthetist, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Else Tønnesen, Professor

Role: STUDY_CHAIR

Faculty of Health, Aarhus University

Locations

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Department of Anesthesiology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SSPS-1-10-72-366-12

Identifier Type: -

Identifier Source: org_study_id