Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift (SSPS)
This study has been completed.
Sponsor:
University of Aarhus
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
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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 June 17, 2013