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Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ropivacaine (sciatic nerve block)
Ropivacaine (lumbar plexus block L2-L4)
Ropivacaine (lumbar plexus block Th12-L1)
Sponsored by
Helios Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Regional Anesthesia, Ultrasonography, Hip Fractures, Lumbosacral Plexus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helios Medical Center Schwerin, Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

intertrochanteric femoral fractures

neck femur fractures

subtrochanteric femoral fractures

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Success Rate (Supplemental Medication)
number of participants with need for supplemental analgesic medication (sufentanil)
Success Rate (Conversion to General Anesthesia)
number of participants with need for conversion to general anesthesia

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2019
Last Updated
February 10, 2021
Sponsor
Helios Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04005404
Brief Title
Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia
Official Title
Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helios Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Regional Anesthesia, Ultrasonography, Hip Fractures, Lumbosacral Plexus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intertrochanteric femoral fractures
Arm Type
Experimental
Arm Description
geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention
Arm Title
neck femur fractures
Arm Type
Experimental
Arm Description
geriatric patients with neck of femur fracture who have consented to the study intervention
Arm Title
subtrochanteric femoral fractures
Arm Type
Experimental
Arm Description
geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention
Intervention Type
Drug
Intervention Name(s)
Ropivacaine (sciatic nerve block)
Other Intervention Name(s)
parasacral sciatic nerve block (sacral plexus)
Intervention Description
injection of 20 ml ropivacaine 0.375%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine (lumbar plexus block L2-L4)
Other Intervention Name(s)
posts compartment block (lumbar plexus L2-L4)
Intervention Description
injection of 20 ml ropivacaine 0.375%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine (lumbar plexus block Th12-L1)
Other Intervention Name(s)
transmuscular quadratus lumborum block (lumbar plexus Th12-L1)
Intervention Description
injection of 20 ml ropivacaine 0.375%
Primary Outcome Measure Information:
Title
Success Rate (Supplemental Medication)
Description
number of participants with need for supplemental analgesic medication (sufentanil)
Time Frame
during surgery
Title
Success Rate (Conversion to General Anesthesia)
Description
number of participants with need for conversion to general anesthesia
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Circulation Stability
Description
number of participants with need for application of ephedrine and/or norepinephrine
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Helios Medical Center Schwerin, Department of Anesthesiology
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19049
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30386022
Citation
Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
Results Reference
background
PubMed Identifier
18354367
Citation
Akkaya T, Comert A, Kendir S, Acar HI, Gumus H, Tekdemir I, Elhan A. Detailed anatomy of accessory obturator nerve blockade. Minerva Anestesiol. 2008 Apr;74(4):119-22.
Results Reference
background
PubMed Identifier
9479711
Citation
Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
Results Reference
background
PubMed Identifier
29397119
Citation
Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.
Results Reference
background
PubMed Identifier
30032877
Citation
Duan X, Coburn M, Rossaint R, Sanders RD, Waesberghe JV, Kowark A. Efficacy of perioperative dexmedetomidine on postoperative delirium: systematic review and meta-analysis with trial sequential analysis of randomised controlled trials. Br J Anaesth. 2018 Aug;121(2):384-397. doi: 10.1016/j.bja.2018.04.046. Epub 2018 Jun 22.
Results Reference
background
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
background
PubMed Identifier
26899415
Citation
Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2(2):CD000521. doi: 10.1002/14651858.CD000521.pub3.
Results Reference
background
PubMed Identifier
28991122
Citation
Guay J, Parker MJ, Griffiths R, Kopp SL. Peripheral Nerve Blocks for Hip Fractures: A Cochrane Review. Anesth Analg. 2018 May;126(5):1695-1704. doi: 10.1213/ANE.0000000000002489.
Results Reference
background
PubMed Identifier
26897445
Citation
Johnston DF, Stafford M, McKinney M, Deyermond R, Dane K. Peripheral nerve blocks with sedation using propofol and alfentanil target-controlled infusion for hip fracture surgery: a review of 6 years in use. J Clin Anesth. 2016 Mar;29:33-9. doi: 10.1016/j.jclinane.2015.10.012. Epub 2016 Feb 2.
Results Reference
background
PubMed Identifier
28263244
Citation
Nielsen TD, Moriggl B, Soballe K, Kolsen-Petersen JA, Borglum J, Bendtsen TF. A Cadaveric Study of Ultrasound-Guided Subpectineal Injectate Spread Around the Obturator Nerve and Its Hip Articular Branches. Reg Anesth Pain Med. 2017 May/Jun;42(3):357-361. doi: 10.1097/AAP.0000000000000587.
Results Reference
background
PubMed Identifier
28551063
Citation
Sa M, Graca R, Reis H, Cardoso JM, Sampaio J, Pinheiro C, Machado D. [Superior gluteal nerve: a new block on the block?]. Braz J Anesthesiol. 2018 Jul-Aug;68(4):400-403. doi: 10.1016/j.bjan.2016.11.001. Epub 2017 May 24.
Results Reference
background
PubMed Identifier
26426575
Citation
Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
Results Reference
background
PubMed Identifier
29140962
Citation
Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
Results Reference
background
PubMed Identifier
22139964
Citation
Taha AM. A simple and successful sonographic technique to identify the sciatic nerve in the parasacral area. Can J Anaesth. 2012 Mar;59(3):263-7. doi: 10.1007/s12630-011-9630-3. Epub 2011 Dec 3.
Results Reference
background
PubMed Identifier
28154824
Citation
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
Results Reference
background
PubMed Identifier
28659127
Citation
Van Waesberghe J, Stevanovic A, Rossaint R, Coburn M. General vs. neuraxial anaesthesia in hip fracture patients: a systematic review and meta-analysis. BMC Anesthesiol. 2017 Jun 28;17(1):87. doi: 10.1186/s12871-017-0380-9.
Results Reference
background
PubMed Identifier
26940645
Citation
White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, Plant F, Williams A, Pappenheim K, Majeed A, Currie CT, Grocott MP. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2). Anaesthesia. 2016 May;71(5):506-14. doi: 10.1111/anae.13415. Epub 2016 Mar 4.
Results Reference
background

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Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

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