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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Procedure: Lumbar plexus block using LUT technique; Procedure: Lumbar plexus block using SSPS technique

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Department of Anesthesiology, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1	30 minutes after injection of local anesthetic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma lidocaine level (mcg/mL)	Chromatography analysis	0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic
Block performance time		From start of probe on the skin until injection of local anesthetic is completed
Patient satisfaction		Immediately after completion of injection of local anesthetic
Mean arterial blood pressure (MAP)	Absolute measure and relative change from pre-block measure	5 minutes after completion of injection of local anesthetic
Cost-effectiveness	Estimated as incremental cost-effectiveness ratio	Block performance time period
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
Sensory blockade of the femoral nerve (cold, warmth, touch, pain)		30 minutes after completion of injection of local anesthetic
Motor blockade of the femoral nerve		40 minutes after completion of injection of the local anesthetic
Motor blockade of the obturator nerve		40 minutes after completion of injection of the local anesthetic
Perineural spread of local anesthetic (with contrast) estimated with MRI		60 minutes after completion of injection of local anesthetic

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Else Tønnesen, Professor, Faculty of Health, Aarhus University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: SSPS-1-10-72-366-12