Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intertrochanteric femoral fractures | Experimental | geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention |
|
| neck femur fractures | Experimental | geriatric patients with neck of femur fracture who have consented to the study intervention |
|
| subtrochanteric femoral fractures | Experimental | geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine (sciatic nerve block) | Drug | injection of 20 ml ropivacaine 0.375% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Circulation Stability | number of participants with need for application of ephedrine and/or norepinephrine | during surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Medical Center Schwerin, Department of Anesthesiology | Schwerin | Mecklenburg-Vorpommern | 19049 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30386022 | Background | 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. | |
| 18354367 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intertrochanteric Femoral Fractures | 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% |
| FG001 | Neck Femur Fractures | 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% |
| FG002 | Subtrochanteric Femoral Fractures | 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% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intertrochanteric Femoral Fractures | 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% |
| BG001 | Neck Femur Fractures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate (Supplemental Medication) | number of participants with need for supplemental analgesic medication (sufentanil) | Posted | Count of Participants | Participants | during surgery |
|
30 days after surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intertrochanteric Femoral Fractures | 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% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epidural anesthesia | Nervous system disorders | Non-systematic Assessment | unintentional epidural anesthesia after lumbar plexus block |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Prof. Dr. Petra Thürmann | Helios Center for Research and Innovation | 0049 (0)202 896-1851 | petra.thuermann@helios-gesundheit.de |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2019 | Jun 29, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2019 | Nov 4, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"
Not provided
Not provided
Not provided
Not provided
|
| Ropivacaine (lumbar plexus block L2-L4) | Drug | injection of 20 ml ropivacaine 0.375% |
|
|
| Ropivacaine (lumbar plexus block Th12-L1) | Drug | injection of 20 ml ropivacaine 0.375% |
|
|
| 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. |
| 9479711 | 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. |
| 29397119 | 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. |
| 30032877 | 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. |
| 30063657 | 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. |
| 26899415 | 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. |
| 28991122 | 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. |
| 26897445 | 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. |
| 28263244 | 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. |
| 28551063 | 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. |
| 26426575 | 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. |
| 29140962 | 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. |
| 22139964 | 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. |
| 28154824 | 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. |
| 28659127 | 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. |
| 26940645 | 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. |
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% |
| BG002 | Subtrochanteric Femoral Fractures | 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% |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Subtrochanteric Femoral Fractures | 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% |
|
|
| Primary | Success Rate (Conversion to General Anesthesia) | number of participants with need for conversion to general anesthesia | Posted | Count of Participants | Participants | during surgery |
|
|
|
| Secondary | Circulation Stability | number of participants with need for application of ephedrine and/or norepinephrine | Posted | Count of Participants | Participants | during surgery |
|
|
|
| 6 |
| 42 |
| 21 |
| 42 |
| 0 |
| 42 |
| EG001 | Neck Femur Fractures | 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% | 3 | 33 | 16 | 33 | 0 | 33 |
| EG002 | Subtrochanteric Femoral Fractures | 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% | 0 | 3 | 0 | 3 | 0 | 3 |
|
| delirium | Nervous system disorders | Non-systematic Assessment | postoperative delirium |
|
| kidney injury | Renal and urinary disorders | Non-systematic Assessment | acute or acute-on-chronic kidney injury |
|
| ventricular tachycardia | Cardiac disorders | Non-systematic Assessment | ventricular tachycardia |
|
| heart failure | Cardiac disorders | Non-systematic Assessment | heart failure |
|
| myocardial infarction | Cardiac disorders | Non-systematic Assessment | myocardial infarction |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | urinary tract infection |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pneumonia |
|
| hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
| wound infection | Surgical and medical procedures | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D007869 |
| Leg Injuries |
| D000588 |
| Amines |