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

NCT01669018 | Completed

• 1 other identifier: SSPS-1-10-72-366-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1

  30 minutes after injection of local anesthetic

Secondary Outcomes (10)

• Plasma lidocaine level (mcg/mL)

  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)

  5 minutes after completion of injection of local anesthetic

• Cost-effectiveness

  Block performance time period

Study Arms (2)

Lumbar ultrasound trident (LUT)

ACTIVE COMPARATOR

Lumbar plexus block using LUT technique

Procedure: Lumbar plexus block using LUT technique

Supra Sacral Parallel Shift (SSPS)

EXPERIMENTAL

Lumbar plexus block using SSPS technique

Procedure: Lumbar plexus block using SSPS technique

Interventions

Lumbar plexus block using LUT technique PROCEDURE

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 ultrasound trident (LUT)

Lumbar plexus block using SSPS technique PROCEDURE

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.

Supra Sacral Parallel Shift (SSPS)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• ASA I (American Society of Anesthesiologists physical status classification)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Anesthesiology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Else Tønnesen, Professor

  Faculty of Health, Aarhus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant anesthetist, associate professor

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

DK (1)