Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

NCT04005404 | Completed Results

• 1 other identifier: A 2018 0237
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures

Keywords

Regional Anesthesia; Ultrasonography; Hip Fractures; Lumbosacral Plexus

Outcome Measures

Primary Outcomes (2)

• Success Rate (Supplemental Medication)

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

  during surgery

• Success Rate (Conversion to General Anesthesia)

  number of participants with need for conversion to general anesthesia

  during surgery

Secondary Outcomes (1)

• Circulation Stability

  during surgery

Study Arms (3)

intertrochanteric femoral fractures

EXPERIMENTAL

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

Drug: Ropivacaine (sciatic nerve block); Drug: Ropivacaine (lumbar plexus block L2-L4); Drug: Ropivacaine (lumbar plexus block Th12-L1)

neck femur fractures

EXPERIMENTAL

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

Drug: Ropivacaine (sciatic nerve block); Drug: Ropivacaine (lumbar plexus block L2-L4); Drug: Ropivacaine (lumbar plexus block Th12-L1)

subtrochanteric femoral fractures

EXPERIMENTAL

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

Drug: Ropivacaine (sciatic nerve block); Drug: Ropivacaine (lumbar plexus block L2-L4); Drug: Ropivacaine (lumbar plexus block Th12-L1)

Interventions

Ropivacaine (sciatic nerve block) DRUG

injection of 20 ml ropivacaine 0.375%

Also known as: parasacral sciatic nerve block (sacral plexus)

intertrochanteric femoral fractures; neck femur fractures; subtrochanteric femoral fractures

Ropivacaine (lumbar plexus block L2-L4) DRUG

injection of 20 ml ropivacaine 0.375%

Also known as: posts compartment block (lumbar plexus L2-L4)

intertrochanteric femoral fractures; neck femur fractures; subtrochanteric femoral fractures

Ropivacaine (lumbar plexus block Th12-L1) DRUG

injection of 20 ml ropivacaine 0.375%

Also known as: transmuscular quadratus lumborum block (lumbar plexus Th12-L1)

intertrochanteric femoral fractures; neck femur fractures; subtrochanteric femoral fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helios Research Center: lead

Study Sites (1)

Helios Medical Center Schwerin, Department of Anesthesiology

Schwerin, Mecklenburg-Vorpommern, 19049, Germany

Location

Related Publications (17)

• 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.

  PMID: 30386022 BACKGROUND

• 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.

  PMID: 18354367 BACKGROUND

• 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.

  PMID: 9479711 BACKGROUND

• 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.

  PMID: 29397119 BACKGROUND

• 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.

  PMID: 30032877 BACKGROUND

• 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.

  PMID: 30063657 BACKGROUND

• 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.

  PMID: 26899415 BACKGROUND

• 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.

  PMID: 28991122 BACKGROUND

• 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.

  PMID: 26897445 BACKGROUND

• 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.

  PMID: 28263244 BACKGROUND

• 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.

  PMID: 28551063 BACKGROUND

• 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.

  PMID: 26426575 BACKGROUND

• 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.

  PMID: 29140962 BACKGROUND

• 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.

  PMID: 22139964 BACKGROUND

• 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.

  PMID: 28154824 BACKGROUND

• 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.

  PMID: 28659127 BACKGROUND

• 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.

  PMID: 26940645 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Director Prof. Dr. Petra Thürmann
• Organization: Helios Center for Research and Innovation

petra.thuermann@helios-gesundheit.de

0049 (0)202 896-1851

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 2, 2019
• Study Start: August 5, 2019
• Primary Completion: June 29, 2020
• Study Completion: June 30, 2020
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)