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Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

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ClinicalTrials.gov Identifier: NCT04005404
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dr.med.Ronald Seidel, Helios Research Center

Brief Summary:
The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

Condition or disease Intervention/treatment Phase
Hip Fractures Drug: Ropivacaine (sciatic nerve block) Drug: Ropivacaine (lumbar plexus block L2-L4) Drug: Ropivacaine (lumbar plexus block Th12-L1) Not Applicable

Detailed Description:

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

After positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography).

The injections are performed parasacrally (blockade of the sacral plexus under the piriformis muscle) and lumbar paravertebrally (psoas compartment block and transmuscular quadratus lumborum block). Per block 20 ml ropivacaine 0.375% is administered (total dose: 225mg ropivacaine).

The study examines the success rate (rate of successfully performed nerve blockade; need for supplemental medication: sufentanil and/or propofol; conversion rate to general anesthesia), circulatory stability (need for application of ephedrine or norepinephrine) and side effects.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intertrochanteric femoral fractures Drug: Ropivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
Other Name: parasacral sciatic nerve block (sacral plexus)

Drug: Ropivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
Other Name: posts compartment block (lumbar plexus L2-L4)

Drug: Ropivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%
Other Name: transmuscular quadratus lumborum block (lumbar plexus Th12-L1)

Experimental: neck femur fractures Drug: Ropivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
Other Name: parasacral sciatic nerve block (sacral plexus)

Drug: Ropivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
Other Name: posts compartment block (lumbar plexus L2-L4)

Drug: Ropivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%
Other Name: transmuscular quadratus lumborum block (lumbar plexus Th12-L1)

Experimental: subtrochanteric femoral fractures Drug: Ropivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
Other Name: parasacral sciatic nerve block (sacral plexus)

Drug: Ropivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
Other Name: posts compartment block (lumbar plexus L2-L4)

Drug: Ropivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%
Other Name: transmuscular quadratus lumborum block (lumbar plexus Th12-L1)




Primary Outcome Measures :
  1. success rate (supplemental medication) [ Time Frame: during surgery ]
    need for supplemental analgesic medication (sufentanil)

  2. success rate (conversion to general anesthesia) [ Time Frame: during surgery ]
    need for conversion to general anesthesia


Secondary Outcome Measures :
  1. circulation stability [ Time Frame: during surgery ]
    need for the application of ephedrine and/or norepinephrine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proximal femoral fracture
  • older then 18 years
  • written informed consent

Exclusion Criteria:

  • local or systematic inflammation
  • allergy to ropivacaine
  • participate in other studies
  • body mass index over 35
  • periprosthetic fractures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005404


Contacts
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Contact: Ronald Seidel +493855204251 ronald.seidel@helios-kliniken.de

Locations
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Germany
Helios Medical Center Schwerin, Department of Anesthesiology Recruiting
Schwerin, Mecklenburg-Vorpommern, Germany, 19049
Contact: Ronald Seidel, MD    +493855204251    ronald.seidel@helios-kliniken.de   
Principal Investigator: Ronald Seidel, MD         
Sponsors and Collaborators
Helios Research Center

Publications of Results:

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Responsible Party: Dr.med.Ronald Seidel, Principal Investigator, Helios Research Center
ClinicalTrials.gov Identifier: NCT04005404     History of Changes
Other Study ID Numbers: A 2018 0237
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr.med.Ronald Seidel, Helios Research Center:
Regional Anesthesia
Ultrasonography
Hip Fractures
Lumbosacral Plexus
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents