Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

February 10, 2021 updated by: Dr.med.Ronald Seidel, Helios Research Center

Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19049
        • Helios Medical Center Schwerin, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intertrochanteric femoral fractures
geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention
Drug: Ropivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • parasacral sciatic nerve block (sacral plexus)
Drug: Ropivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • posts compartment block (lumbar plexus L2-L4)
Drug: Ropivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • transmuscular quadratus lumborum block (lumbar plexus Th12-L1)
Experimental: neck femur fractures
geriatric patients with neck of femur fracture who have consented to the study intervention
Drug: Ropivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • parasacral sciatic nerve block (sacral plexus)
Drug: Ropivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • posts compartment block (lumbar plexus L2-L4)
Drug: Ropivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • transmuscular quadratus lumborum block (lumbar plexus Th12-L1)
Experimental: subtrochanteric femoral fractures
geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention
Drug: Ropivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • parasacral sciatic nerve block (sacral plexus)
Drug: Ropivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • posts compartment block (lumbar plexus L2-L4)
Drug: Ropivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%
Other Names:
  • transmuscular quadratus lumborum block (lumbar plexus Th12-L1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate (Supplemental Medication)
Time Frame: during surgery
number of participants with need for supplemental analgesic medication (sufentanil)
during surgery
Success Rate (Conversion to General Anesthesia)
Time Frame: during surgery
number of participants with need for conversion to general anesthesia
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulation Stability
Time Frame: during surgery
number of participants with need for application of ephedrine and/or norepinephrine
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helios Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

June 29, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 29, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A 2018 0237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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