NCT02593370

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1 month

First QC Date

October 28, 2015

Last Update Submit

February 11, 2016

Conditions

Hip FracturesAnesthesia LocalPain, Perioperative

Keywords

Hip surgery anesthesiaPerioperative analgesia

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (11)

  • Plasma lidocaine

    Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after intervention. Presented 10 months after LVLP

  • Time for preparation

    Estimated prior to intervention. Presented 10 months after LVLP

  • Block procedure time

    Estimated during intervention. Presented 10 months after LVLP

  • Injection site

    Estimated at the end of the intervention. Presented 10 months after LVLP

  • Block needle depth

    Estimated at the end of the intervention. Presented 10 months after LVLP

  • +6 more secondary outcomes

Study Arms (2)

Suprasacral Parallel Shift guided by US/MR image fusion

EXPERIMENTAL

Use of ultrasound/MR image fusion guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine).

Drug: Lidocaine-epinephrine added gadoterate meglumine

Suprasacral Parallel Shift guided by US

ACTIVE COMPARATOR

Use of ultrasound guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine).

Drug: Lidocaine-epinephrine added gadoterate meglumine

Interventions

Lidocaine-epinephrine added gadoterate meglumineDRUG
Suprasacral Parallel Shift guided by USSuprasacral Parallel Shift guided by US/MR image fusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Strid JM, Pedersen EM, Al-Karradi SN, Bendtsen MA, Bjorn S, Dam M, Daugaard M, Hansen MS, Linnet KD, Borglum J, Soballe K, Bendtsen TF. Real-Time Ultrasound/MRI Fusion for Suprasacral Parallel Shift Approach to Lumbosacral Plexus Blockade and Analysis of Injectate Spread: An Exploratory Randomized Controlled Trial. Biomed Res Int. 2017;2017:1873209. doi: 10.1155/2017/1873209. Epub 2017 Mar 15.

    PMID: 28396863DERIVED

MeSH Terms

Conditions

Hip FracturesPain

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research anesthetist, ass. professor, PhD

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 2, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

DK(1)