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Clinical Trials/NCT04005404
NCT04005404
Completed
N/A

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

Helios Research Center1 site in 1 country80 target enrollmentAugust 5, 2019

Overview

Phase
N/A
Intervention
Ropivacaine (sciatic nerve block)
Conditions
Hip Fractures
Sponsor
Helios Research Center
Enrollment
80
Locations
1
Primary Endpoint
Success Rate (Conversion to General Anesthesia)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2019
End Date
June 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Helios Research Center
Responsible Party
Principal Investigator
Principal Investigator

Dr.med.Ronald Seidel

Principal Investigator

Helios Research Center

Eligibility 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

Arms & Interventions

intertrochanteric femoral fractures

geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention

Intervention: Ropivacaine (sciatic nerve block)

intertrochanteric femoral fractures

geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention

Intervention: Ropivacaine (lumbar plexus block L2-L4)

intertrochanteric femoral fractures

geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention

Intervention: Ropivacaine (lumbar plexus block Th12-L1)

neck femur fractures

geriatric patients with neck of femur fracture who have consented to the study intervention

Intervention: Ropivacaine (sciatic nerve block)

neck femur fractures

geriatric patients with neck of femur fracture who have consented to the study intervention

Intervention: Ropivacaine (lumbar plexus block L2-L4)

neck femur fractures

geriatric patients with neck of femur fracture who have consented to the study intervention

Intervention: Ropivacaine (lumbar plexus block Th12-L1)

subtrochanteric femoral fractures

geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention

Intervention: Ropivacaine (sciatic nerve block)

subtrochanteric femoral fractures

geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention

Intervention: Ropivacaine (lumbar plexus block L2-L4)

subtrochanteric femoral fractures

geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention

Intervention: Ropivacaine (lumbar plexus block Th12-L1)

Outcomes

Primary Outcomes

Success Rate (Conversion to General Anesthesia)

Time Frame: during surgery

number of participants with need for conversion to general anesthesia

Success Rate (Supplemental Medication)

Time Frame: during surgery

number of participants with need for supplemental analgesic medication (sufentanil)

Secondary Outcomes

  • Circulation Stability(during surgery)

Study Sites (1)

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