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

Hip Fracture Clinical Trial

— SSPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669018
• Other study ID #: SSPS-1-10-72-366-12
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: January 30, 2013
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1		30 minutes after injection of local anesthetic	No
Secondary	Plasma lidocaine level (mcg/mL)	Chromatography analysis	0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic	Yes
Secondary	Block performance time		From start of probe on the skin until injection of local anesthetic is completed	No
Secondary	Patient satisfaction		Immediately after completion of injection of local anesthetic	No
Secondary	Mean arterial blood pressure (MAP)	Absolute measure and relative change from pre-block measure	5 minutes after completion of injection of local anesthetic	Yes
Secondary	Cost-effectiveness	Estimated as incremental cost-effectiveness ratio	Block performance time period	No
Secondary	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	No
Secondary	Sensory blockade of the femoral nerve (cold, warmth, touch, pain)		30 minutes after completion of injection of local anesthetic	No
Secondary	Motor blockade of the femoral nerve		40 minutes after completion of injection of the local anesthetic	No
Secondary	Motor blockade of the obturator nerve		40 minutes after completion of injection of the local anesthetic	No
Secondary	Perineural spread of local anesthetic (with contrast) estimated with MRI		60 minutes after completion of injection of local anesthetic	Yes