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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas F. Bendtsen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01669018
First received: August 16, 2012
Last updated: January 30, 2013
Last verified: January 2013

August 16, 2012
January 30, 2013
August 2012
December 2012   (final data collection date for primary outcome measure)
Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1 [ Time Frame: 30 minutes after injection of local anesthetic ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01669018 on ClinicalTrials.gov Archive Site
  • Plasma lidocaine level (mcg/mL) [ Time Frame: 0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic ] [ Designated as safety issue: Yes ]
    Chromatography analysis
  • Block performance time [ Time Frame: From start of probe on the skin until injection of local anesthetic is completed ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: Immediately after completion of injection of local anesthetic ] [ Designated as safety issue: No ]
  • Mean arterial blood pressure (MAP) [ Time Frame: 5 minutes after completion of injection of local anesthetic ] [ Designated as safety issue: Yes ]
    Absolute measure and relative change from pre-block measure
  • Cost-effectiveness [ Time Frame: Block performance time period ] [ Designated as safety issue: No ]
    Estimated as incremental cost-effectiveness ratio
  • 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 ] [ Designated as safety issue: No ]
  • Sensory blockade of the femoral nerve (cold, warmth, touch, pain) [ Time Frame: 30 minutes after completion of injection of local anesthetic ] [ Designated as safety issue: No ]
  • Motor blockade of the femoral nerve [ Time Frame: 40 minutes after completion of injection of the local anesthetic ] [ Designated as safety issue: No ]
  • Motor blockade of the obturator nerve [ Time Frame: 40 minutes after completion of injection of the local anesthetic ] [ Designated as safety issue: No ]
  • Perineural spread of local anesthetic (with contrast) estimated with MRI [ Time Frame: 60 minutes after completion of injection of local anesthetic ] [ Designated as safety issue: Yes ]
  • Plasma-lidocaine [ Time Frame: 0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic ] [ Designated as safety issue: Yes ]
  • Block performance time [ Time Frame: From start of probe on the skin until injection of local anesthetic is completed ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: Immediately after completion of injection of local anesthetic ] [ Designated as safety issue: No ]
  • Mean arterial blood pressure (MAP) [ Time Frame: 5 minutes after completion of injection of local anesthetic ] [ Designated as safety issue: Yes ]
    Absolute measure and relative change from pre-block measure
  • Cost-effectiveness [ Time Frame: Block performance time period ] [ Designated as safety issue: No ]
    Estimated as incremental cost-effectiveness ratio
  • 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 ] [ Designated as safety issue: No ]
  • Sensory blockade of the femoral nerve (cold, warmth, touch, pain) [ Time Frame: 30 minutes after completion of injection of local anesthetic ] [ Designated as safety issue: No ]
  • Motor blockade of the femoral nerve [ Time Frame: 40 minutes after completion of injection of the local anesthetic ] [ Designated as safety issue: No ]
  • Motor blockade of the obturator nerve [ Time Frame: 40 minutes after completion of injection of the local anesthetic ] [ Designated as safety issue: No ]
  • Perineural spread of local anesthetic (with contrast) estimated with MRI [ Time Frame: 60 minutes after completion of injection of local anesthetic ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift
The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Hip Fracture
  • Procedure: 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.
  • 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.
  • Active Comparator: Lumbar ultrasound trident (LUT)
    Lumbar plexus block using LUT technique
    Intervention: Procedure: Lumbar plexus block using LUT technique
  • Experimental: Supra Sacral Parallel Shift (SSPS)
    Lumbar plexus block using SSPS technique
    Intervention: Procedure: Lumbar plexus block using SSPS technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01669018
SSPS-1-10-72-366-12
No
Thomas F. Bendtsen, University of Aarhus
University of Aarhus
Not Provided
Study Chair: Else Tønnesen, Professor Faculty of Health, Aarhus University
University of Aarhus
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP