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Completed

NCT Number: NCT01669018

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 30 minutes after injection of local anesthetic

Secondary outcomes

  1. Plasma lidocaine level (mcg/mL)

    Time frame: 0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic

    Chromatography analysis

  2. Block performance time

    Time frame: From start of probe on the skin until injection of local anesthetic is completed

  3. Patient satisfaction

    Time frame: Immediately after completion of injection of local anesthetic

  4. Mean arterial blood pressure (MAP)

    Time frame: 5 minutes after completion of injection of local anesthetic

    Absolute measure and relative change from pre-block measure

  5. Cost-effectiveness

    Time frame: Block performance time period

    Estimated as incremental cost-effectiveness ratio

  6. 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

  7. Sensory blockade of the femoral nerve (cold, warmth, touch, pain)

    Time frame: 30 minutes after completion of injection of local anesthetic

  8. Motor blockade of the femoral nerve

    Time frame: 40 minutes after completion of injection of the local anesthetic

  9. Motor blockade of the obturator nerve

    Time frame: 40 minutes after completion of injection of the local anesthetic

  10. Perineural spread of local anesthetic (with contrast) estimated with MRI

    Time frame: 60 minutes after completion of injection of local anesthetic

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: SSPS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2012
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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