Clinical trial NCT01669018: Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift
Official title: The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1
timeFrame: 30 minutes after injection of local anesthetic
Secondary outcomes:
measure: Plasma lidocaine level (mcg/mL)
timeFrame: 0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic
measure: Block performance time
timeFrame: From start of probe on the skin until injection of local anesthetic is completed
measure: Patient satisfaction
timeFrame: Immediately after completion of injection of local anesthetic
measure: Mean arterial blood pressure (MAP)
timeFrame: 5 minutes after completion of injection of local anesthetic
measure: Cost-effectiveness
timeFrame: Block performance time period
measure: Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)
timeFrame: 30 minutes after completed injection of local anesthetic
measure: Sensory blockade of the femoral nerve (cold, warmth, touch, pain)
timeFrame: 30 minutes after completion of injection of local anesthetic
measure: Motor blockade of the femoral nerve
timeFrame: 40 minutes after completion of injection of the local anesthetic
measure: Motor blockade of the obturator nerve
timeFrame: 40 minutes after completion of injection of the local anesthetic
measure: Perineural spread of local anesthetic (with contrast) estimated with MRI
timeFrame: 60 minutes after completion of injection of local anesthetic
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anesthesiology, Aarhus University Hospital
Study officials:
affiliation: Faculty of Health, Aarhus University
name: Else Tønnesen, Professor
role: STUDY_CHAIR
References: