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
  Purpose

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.


Condition Intervention
Hip Fracture
Procedure: Lumbar plexus block using LUT technique
Procedure: Lumbar plexus block using SSPS technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lumbar ultrasound trident (LUT)
Lumbar plexus block using LUT technique
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.
Experimental: Supra Sacral Parallel Shift (SSPS)
Lumbar plexus block using SSPS technique
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669018

Locations
Denmark
Department of Anesthesiology, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Else Tønnesen, Professor Faculty of Health, Aarhus University
  More Information

No publications provided

Responsible Party: Thomas F. Bendtsen, Consultant anesthetist, associate professor, University of Aarhus
ClinicalTrials.gov Identifier: NCT01669018     History of Changes
Other Study ID Numbers: SSPS-1-10-72-366-12
Study First Received: August 16, 2012
Last Updated: January 30, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 21, 2014