Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block

Hip Fractures Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593370
• Other study ID #: AUH-TFB-SSPS
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2015
• Last updated: February 11, 2016
• Start date: October 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.

Description:

The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a one-injection nerve block of the lower part of the lumbar plexus and the upper part of the sacral plexus (Suprasacral Parallel Shift, SSPS) to achieve analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 with SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound by estimating sensory block of in healthy volunteers by estimating the sensory block of dermatomes of the terminal nerves in healthy volunteers.

The secondary objective is to estimate a) preparation and b) procedure time, c) injection site and d) depth, e) discomfort, f) change in MAP, g) plasma lidocaine pharmacokinetics, h) motor and i) sensory block, j) perineural and k) epidural spread of lidocaine-epinephrine added gadotorate meglumine on MRI, and l) cost-effectiveness of SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound.

The investigators hypothesize that block success is higher for SSPS guided by ultrasound/MR image fusion than for SSPS guided by ultrasound.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

• Volunteers who has given their written and oral informed consent to participate in the study after having fully understood the content and the limitations of the protocol.

• Normal healthy person (American Society of Anesthesiology [ASA] Classification I)

Exclusion Criteria:

• Volunteers not able to cooperate in the study

• Volunteers not able to understand or speak Danish

• Daily use of analgesics

• Allergy against the medicines used in the study

• Drug abuse (according to the investigator's judgement)

• Alcohol consumption greater than the recommendations of the Danish National Board of Health

• Contraindication for MRI including pregnancy

• Volunteer in whom nerve blocks are not possible due to technical reasons

• Volunteer who are incompetent (ie. surrogate consent is not accepted)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia Local
• Hip Fractures
• Pain, Perioperative

Intervention

Drug:
• Lidocaine-epinephrine added gadoterate meglumine

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology and Intensive Care, Aarhus University Hospital	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
Thomas F. Bendtsen	Aarhus University Hospital, AP Moeller Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Block success	Block success of the clinical relevant lumbosacral nerves that innervate the hip joint capsule estimated as significant motor block of the obturator nerve, the femoral nerve, and the lumbosacral trunk. Motor block is a significant proxy marker of sensory block. Motor block (muscle strength, mmHg) is assessed with a handheld dynamometer.	Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP).	Yes
Secondary	Plasma lidocaine		Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after intervention. Presented 10 months after LVLP	Yes
Secondary	Time for preparation	Time for preparation in seconds is defined as the time of placement of the volunteer on the bed until the end of pre-ultrasound scanning	Estimated prior to intervention. Presented 10 months after LVLP	No
Secondary	Block procedure time	Block procedure time in seconds is defined as the time of the placement of the ultrasound probe on the skin to until the block needle is pulled out after injection of local anesthetics	Estimated during intervention. Presented 10 months after LVLP	No
Secondary	Injection site		Estimated at the end of the intervention. Presented 10 months after LVLP	Yes
Secondary	Block needle depth		Estimated at the end of the intervention. Presented 10 months after LVLP	Yes
Secondary	Discomfort	Estimated on numeric rating scale 0-10	Estimated immediately after the intervention. Presented 10 months after LVLP	No
Secondary	Mean arterial pressure change		Mean arterial pressure is measured prior intervention and 5 min after intervention. Presented 10 months after LVLP	Yes
Secondary	Sensory (cold, warm, touch, pain) block of the dermatomes T12-S3 and the lateral femoral cutaneous nerve		Estimated 50 min after intervention. Presented 10 months after LVLP	Yes
Secondary	Perineural spread of local anesthetics added gadoterate meglumine		Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP	Yes
Secondary	Epidural spread of local anesthetics added gadoterate meglumine		Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP	Yes
Secondary	Cost-effectiveness (ICER)	ICER is estimated as the difference in mean marginal cost of the blocks.	Calculated after LVLP. Presented 10 months after the last visit of the last volunteer	No