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Completed

NCT Number: NCT04005404

Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

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

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Medical Center Schwerin, Department of Anesthesiology

Schwerin, Mecklenburg-Vorpommern, 19049, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine (sciatic nerve block)

Drug

injection of 20 ml ropivacaine 0.375%

Other names: parasacral sciatic nerve block (sacral plexus)

Ropivacaine (lumbar plexus block L2-L4)

Drug

injection of 20 ml ropivacaine 0.375%

Other names: posts compartment block (lumbar plexus L2-L4)

Ropivacaine (lumbar plexus block Th12-L1)

Drug

injection of 20 ml ropivacaine 0.375%

Other names: transmuscular quadratus lumborum block (lumbar plexus Th12-L1)

Primary outcomes

  1. Success Rate (Supplemental Medication)

    Time frame: during surgery

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

  2. Success Rate (Conversion to General Anesthesia)

    Time frame: during surgery

    number of participants with need for conversion to general anesthesia

Secondary outcomes

  1. Circulation Stability

    Time frame: during surgery

    number of participants with need for application of ephedrine and/or norepinephrine

Sponsors and collaborators

Lead sponsor

Helios Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2019
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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