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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lumbar plexus block using LUT technique
Lumbar plexus block using SSPS technique
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Anesthesiology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lumbar ultrasound trident (LUT)

Supra Sacral Parallel Shift (SSPS)

Arm Description

Lumbar plexus block using LUT technique

Lumbar plexus block using SSPS technique

Outcomes

Primary Outcome Measures

Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1

Secondary Outcome Measures

Plasma lidocaine level (mcg/mL)
Chromatography analysis
Block performance time
Patient satisfaction
Mean arterial blood pressure (MAP)
Absolute measure and relative change from pre-block measure
Cost-effectiveness
Estimated as incremental cost-effectiveness ratio
Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)
Sensory blockade of the femoral nerve (cold, warmth, touch, pain)
Motor blockade of the femoral nerve
Motor blockade of the obturator nerve
Perineural spread of local anesthetic (with contrast) estimated with MRI

Full Information

First Posted
August 16, 2012
Last Updated
January 30, 2013
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01669018
Brief Title
Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift
Acronym
SSPS
Official Title
The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar ultrasound trident (LUT)
Arm Type
Active Comparator
Arm Description
Lumbar plexus block using LUT technique
Arm Title
Supra Sacral Parallel Shift (SSPS)
Arm Type
Experimental
Arm Description
Lumbar plexus block using SSPS technique
Intervention Type
Procedure
Intervention Name(s)
Lumbar plexus block using LUT technique
Intervention Description
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
Intervention Name(s)
Lumbar plexus block using SSPS technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1
Time Frame
30 minutes after injection of local anesthetic
Secondary Outcome Measure Information:
Title
Plasma lidocaine level (mcg/mL)
Description
Chromatography analysis
Time Frame
0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic
Title
Block performance time
Time Frame
From start of probe on the skin until injection of local anesthetic is completed
Title
Patient satisfaction
Time Frame
Immediately after completion of injection of local anesthetic
Title
Mean arterial blood pressure (MAP)
Description
Absolute measure and relative change from pre-block measure
Time Frame
5 minutes after completion of injection of local anesthetic
Title
Cost-effectiveness
Description
Estimated as incremental cost-effectiveness ratio
Time Frame
Block performance time period
Title
Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)
Time Frame
30 minutes after completed injection of local anesthetic
Title
Sensory blockade of the femoral nerve (cold, warmth, touch, pain)
Time Frame
30 minutes after completion of injection of local anesthetic
Title
Motor blockade of the femoral nerve
Time Frame
40 minutes after completion of injection of the local anesthetic
Title
Motor blockade of the obturator nerve
Time Frame
40 minutes after completion of injection of the local anesthetic
Title
Perineural spread of local anesthetic (with contrast) estimated with MRI
Time Frame
60 minutes after completion of injection of local anesthetic

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Else Tønnesen, Professor
Organizational Affiliation
Faculty of Health, Aarhus University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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