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

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01669018
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fracture	Procedure: Lumbar plexus block using LUT technique; Procedure: Lumbar plexus block using SSPS technique	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1 [30 minutes after injection of local anesthetic]

Secondary Outcome Measures

1. Plasma lidocaine level (mcg/mL) [0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic]

   Chromatography analysis

2. Block performance time [From start of probe on the skin until injection of local anesthetic is completed]

3. Patient satisfaction [Immediately after completion of injection of local anesthetic]

4. Mean arterial blood pressure (MAP) [5 minutes after completion of injection of local anesthetic]

   Absolute measure and relative change from pre-block measure

5. Cost-effectiveness [Block performance time period]

   Estimated as incremental cost-effectiveness ratio

6. Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain) [30 minutes after completed injection of local anesthetic]

7. Sensory blockade of the femoral nerve (cold, warmth, touch, pain) [30 minutes after completion of injection of local anesthetic]

8. Motor blockade of the femoral nerve [40 minutes after completion of injection of the local anesthetic]

9. Motor blockade of the obturator nerve [40 minutes after completion of injection of the local anesthetic]

10. Perineural spread of local anesthetic (with contrast) estimated with MRI [60 minutes after completion of injection of local anesthetic]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas F. Bendtsen, Consultant anesthetist, associate professor, University of Aarhus
• ClinicalTrials.gov Identifier: NCT01669018
• Other Study ID Numbers: SSPS-1-10-72-366-12
• First Posted: Aug 20, 2012
• Last Update Posted: Jan 31, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Hip Fractures

Study Results

No Results Posted as of Jan 31, 2013