Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus

NCT02255591 | Completed Phase 4 DMC

• 2 other identifiers: AUH-TFB-SR2013-005346-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers. Secondary objectives include a) estimates of number and depth of needle injections, distance of injection site from the midline, minimal electric nerve stimulation to trigger muscular response and the type of response, and volunteer discomfort during block injection, b) measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e) perineural and epidural distribution of local anesthetics added contrast visualized on magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy volunteers. The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound technique, and that the success rate of the Shamrock technique is equal to or higher than the Lumbar Ultrasound Trident technique.

Conditions

Hip Fractures; Anesthesia Local; Pain, Postoperative

Keywords

Hip surgery anesthesia; Perioperative analgesia

Outcome Measures

Primary Outcomes (1)

• Block performance time

  Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics.

  Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.

Secondary Outcomes (15)

• Number of needle feeds

  Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.

• Discomfort during block placement

  Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.

• Plasma Lidocaine

  Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after block placement. Presented 10 months after the last visit of the last volunteer.

• Mear arterial pressure

  Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.

• Cost-effectiveness

  Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.

Study Arms (2)

Shamrock

EXPERIMENTAL

Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium.

Drug: Lidocaine-adrenaline added gadolinium.

Lumbar Ultrasound Trident

ACTIVE COMPARATOR

Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium.

Drug: Lidocaine-adrenaline added gadolinium.

Interventions

Lidocaine-adrenaline added gadolinium. DRUG

Lumbar Ultrasound Trident; Shamrock

Eligibility Criteria

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

You may qualify if:

• Male
• Age ≥ 18 years
• Volunteers who have given their written and oral consent to participate in the study after fully understanding the content and the limitations of the protocol
• Normal healthy volunteer (American Society of Anesthesiology (ASA) Classification I)

You may not qualify if:

• Volunteers not able to cooperate for the study
• Volunteers not able to understand Danish
• Daily use of analgesics
• Allergy against the medicines used in the study
• Drug abuse (according to the investigator's judgement)
• Alcohol consumption larger than the recommendations of the Danish National Board of Health
• Volunteers in whom nerve blocks are not possible due to technical reasons
• Volunteers who meet any contraindication for MRI including claustrophobia
• Volunteers who are incompetent, i.e. surrogate consent is not accepted

Sponsors & Collaborators

• University of Aarhus: lead
• AP Moeller Foundation: collaborator

Study Sites (1)

Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital

Aarhus C, DK-8000, Denmark

Location

Related Publications (8)

• de Visme V, Picart F, Le Jouan R, Legrand A, Savry C, Morin V. Combined lumbar and sacral plexus block compared with plain bupivacaine spinal anesthesia for hip fractures in the elderly. Reg Anesth Pain Med. 2000 Mar-Apr;25(2):158-62. doi: 10.1053/rapm.2000.0250158.

  PMID: 10746528 BACKGROUND

• Kirchmair L, Entner T, Kapral S, Mitterschiffthaler G. Ultrasound guidance for the psoas compartment block: an imaging study. Anesth Analg. 2002 Mar;94(3):706-10; table of contents. doi: 10.1097/00000539-200203000-00042.

  PMID: 11867402 BACKGROUND

• Kirchmair L, Entner T, Wissel J, Moriggl B, Kapral S, Mitterschiffthaler G. A study of the paravertebral anatomy for ultrasound-guided posterior lumbar plexus block. Anesth Analg. 2001 Aug;93(2):477-81, 4th contents page. doi: 10.1097/00000539-200108000-00047.

  PMID: 11473883 BACKGROUND

• Morimoto M, Kim JT, Popovic J, Jain S, Bekker A. Ultrasound-guided lumbar plexus block for open reduction and internal fixation of hip fracture. Pain Pract. 2006 Jun;6(2):124-6. doi: 10.1111/j.1533-2500.2006.00074.x.

  PMID: 17309721 BACKGROUND

• Doi K, Sakura S, Hara K. A modified posterior approach to lumbar plexus block using a transverse ultrasound image and an approach from the lateral border of the transducer. Anaesth Intensive Care. 2010 Jan;38(1):213-4. No abstract available.

  PMID: 20191806 BACKGROUND

• Madison SJ, Ilfeld BM, Loland VJ, Mariano ER. Posterior lumbar plexus perineural catheter insertion by ultrasound guidance alone. Acta Anaesthesiol Scand. 2011 Sep;55(8):1031-2. doi: 10.1111/j.1399-6576.2011.02489.x. Epub 2011 Jul 20. No abstract available.

  PMID: 21770905 BACKGROUND

• Karmakar MK, Ho AM, Li X, Kwok WH, Tsang K, Ngan Kee WD. Ultrasound-guided lumbar plexus block through the acoustic window of the lumbar ultrasound trident. Br J Anaesth. 2008 Apr;100(4):533-7. doi: 10.1093/bja/aen026.

  PMID: 18344573 BACKGROUND

• Strid JMC, Sauter AR, Ullensvang K, Andersen MN, Daugaard M, Bendtsen MAF, Soballe K, Pedersen EM, Borglum J, Bendtsen TF. Ultrasound-guided lumbar plexus block in volunteers; a randomized controlled trial. Br J Anaesth. 2017 Mar 1;118(3):430-438. doi: 10.1093/bja/aew464.

  PMID: 28203808 DERIVED

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Thomas F Bendtsen, MD,PhD,Prof.

  Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 2, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 1, 2015

Record last verified: 2014-09

Locations

DK (1)