Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005404
• Other study ID #: A 2018 0237
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2021
• Source: Helios Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Ropivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
• Ropivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
• Ropivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%

Locations

Country	Name	City	State
Germany	Helios Medical Center Schwerin, Department of Anesthesiology	Schwerin	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
Helios Research Center

Country where clinical trial is conducted

Germany, 

References & 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. — View 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. — View 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. — View Citation

Coburn M, Sanders RD, Maze M, Nguyên-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognù 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. — View 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. — View Citation

Girón-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. — View Citation

Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2:CD000521. doi: 10.1002/14651858.CD000521.pub3. Review. — View 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. Review. — View 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. — View Citation

Nielsen TD, Moriggl B, Søballe K, Kolsen-Petersen JA, Børglum 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. — View Citation

Sá M, Graça R, Reis H, Cardoso JM, Sampaio J, Pinheiro C, Machado D. [Superior gluteal nerve: a new block on the block?]. Rev Bras Anestesiol. 2018 Jul - Aug;68(4):400-403. doi: 10.1016/j.bjan.2016.11.001. Epub 2017 May 24. Portuguese. — View Citation

Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Børglum 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate (Supplemental Medication)	number of participants with need for supplemental analgesic medication (sufentanil)	during surgery
Primary	Success Rate (Conversion to General Anesthesia)	number of participants with need for conversion to general anesthesia	during surgery
Secondary	Circulation Stability	number of participants with need for application of ephedrine and/or norepinephrine	during surgery