Hip Fractures Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate the Impact of Integrated Preoperative Fascia Iliaca Compartment Block (FICB) for Fast-track Surgery in Elderly Hip Fracture
NCT number | NCT05857462 |
Other study ID # | CREC015/2023 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2023 |
Est. completion date | March 2026 |
This prospective randomized controlled study is aimed to determine the advantages of post-admission fascia iliaca compartment block (FICB) in geriatric hip fracture surgery combination with multimodal analgesia compared with no post-admission FICB. The primary outcome is incidence of delirium during hospital admission. Secondary outcomes are incidence of delirium at hospital discharge, pre- and post-operative pain intensity, peri-operative complications, opioid-related side effects, post-operative complications and length of hospital stay, and morbidities and mortality (in-hospital and 30 days).
Status | Recruiting |
Enrollment | 420 |
Est. completion date | March 2026 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Patients who are aged =65 , <85 years old and diagnose hip fracture in 8 hospitals 2. Planed for fast-track hip surgery 3. Isolated acute hip fracture 4. Pain on admission during movement = 4 (moderate pain) Exclusion Criteria: 1. refusal to participate the study 2. ASA physical status >III 2. duration of fracture more than 7 days before admission 3. hip fracture after/at previous instrumentation 4. hip fracture causing by a traffic accident or high energy force 5. suspected pathologic fracture 6. unable to communication 7. abnormal consciousness or severe cognitive dysfunction that could not communication such as mental retardation, severe Alzheimer's disease and schizophenia 8. allergy to local anesthetic drug |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok Noi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Ministry of Health, Thailand |
Thailand,
Chaysri R, Leerapun T, Klunklin K, Chiewchantanakit S, Luevitoonvechkij S, Rojanasthien S. Factors related to mortality after osteoporotic hip fracture treatment at Chiang Mai University Hospital, Thailand, during 2006 and 2007. J Med Assoc Thai. 2015 Jan;98(1):59-64. — View Citation
Chotanaphuti T, Jareonarpornwatana A, Laoruengthana A. The mortality rate after thromboembolism prophylaxis in the hip fracture surgery. J Med Assoc Thai. 2009 Dec;92 Suppl 6:S115-9. — View Citation
Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133. — View Citation
Fadhlillah F, Chan D, Pelosi P, Rubulotta F. Systematic review and meta-analysis of single injection fascia iliaca blocks in the peri-operative management of patients with hip fractures. Minerva Anestesiol. 2019 Nov;85(11):1211-1218. doi: 10.23736/S0375-9393.19.13535-3. Epub 2019 Jul 4. — View Citation
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Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2. — View Citation
Groot L, Dijksman LM, Simons MP, Zwartsenburg MM, Rebel JR. Single Fascia Iliaca Compartment Block is Safe and Effective for Emergency Pain Relief in Hip-fracture Patients. West J Emerg Med. 2015 Dec;16(7):1188-93. doi: 10.5811/westjem.2015.10.28270. Epub 2015 Dec 14. — View Citation
Hao J, Dong B, Zhang J, Luo Z. Pre-emptive analgesia with continuous fascia iliaca compartment block reduces postoperative delirium in elderly patients with hip fracture. A randomized controlled trial. Saudi Med J. 2019 Sep;40(9):901-906. doi: 10.15537/smj.2019.9.24483. — View Citation
Haugan K, Johnsen LG, Basso T, Foss OA. Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care. BMJ Open. 2017 Aug 29;7(8):e015574. doi: 10.1136/bmjopen-2016-015574. — View Citation
Hsu YP, Hsu CW, Bai CH, Cheng SW, Chen C. Fascia iliaca compartment block versus intravenous analgesic for positioning of femur fracture patients before a spinal block: A PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Dec;97(49):e13502. doi: 10.1097/MD.0000000000013502. — View Citation
Jiang M, Liu S, Deng H, Liang X, Bo Z. The efficacy and safety of fast track surgery (FTS) in patients after hip fracture surgery: a meta-analysis. J Orthop Surg Res. 2021 Feb 27;16(1):162. doi: 10.1186/s13018-021-02277-w. — View Citation
Kacha NJ, Jadeja CA, Patel PJ, Chaudhari HB, Jivani JR, Pithadia VS. Comparative Study for Evaluating Efficacy of Fascia Iliaca Compartment Block for Alleviating Pain of Positioning for Spinal Anesthesia in Patients with Hip and Proximal Femur Fractures. Indian J Orthop. 2018 Mar-Apr;52(2):147-153. doi: 10.4103/ortho.IJOrtho_298_16. — View Citation
Kulachote N, Sa-Ngasoongsong P, Sirisreetreerux N, Wongsak S, Suphachatwong C, Wajanavisit W, Kawinwonggowit V. The Impacts of Early Hip Surgery in High-Risk Elderly Taking Antithrombotic Agents and Afflicted with Intertrochanteric Fracture. J Med Assoc Thai. 2015 Sep;98 Suppl 8:S76-81. — View Citation
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Lewis PM, Waddell JP. When is the ideal time to operate on a patient with a fracture of the hip? : a review of the available literature. Bone Joint J. 2016 Dec;98-B(12):1573-1581. doi: 10.1302/0301-620X.98B12.BJJ-2016-0362.R2. — View Citation
Li H, Zheng ZN, Zhang NR, Guo J, Wang K, Wang W, Li LG, Jin J, Tang J, Liao YJ, Jin SQ. Intra-operative open-lung ventilatory strategy reduces postoperative complications after laparoscopic colorectal cancer resection: A randomised controlled trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1042-1051. doi: 10.1097/EJA.0000000000001580. — View Citation
Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19. — View Citation
Munoz Vives JM, Jornet-Gibert M, Camara-Cabrera J, Esteban PL, Brunet L, Delgado-Flores L, Camacho-Carrasco P, Torner P, Marcano-Fernandez F; Spanish HIP-COVID Investigation Group. Mortality Rates of Patients with Proximal Femoral Fracture in a Worldwide Pandemic: Preliminary Results of the Spanish HIP-COVID Observational Study. J Bone Joint Surg Am. 2020 Jul 1;102(13):e69. doi: 10.2106/JBJS.20.00686. — View Citation
Nie H, Yang YX, Wang Y, Liu Y, Zhao B, Luan B. Effects of continuous fascia iliaca compartment blocks for postoperative analgesia in patients with hip fracture. Pain Res Manag. 2015 Jul-Aug;20(4):210-2. doi: 10.1155/2015/872651. Epub 2015 Jun 30. — View Citation
Pincus D, Ravi B, Wasserstein D, Huang A, Paterson JM, Nathens AB, Kreder HJ, Jenkinson RJ, Wodchis WP. Association Between Wait Time and 30-Day Mortality in Adults Undergoing Hip Fracture Surgery. JAMA. 2017 Nov 28;318(20):1994-2003. doi: 10.1001/jama.2017.17606. — View Citation
Pollmann CT, Rotterud JH, Gjertsen JE, Dahl FA, Lenvik O, Aroen A. Fast track hip fracture care and mortality - an observational study of 2230 patients. BMC Musculoskelet Disord. 2019 May 24;20(1):248. doi: 10.1186/s12891-019-2637-6. — View Citation
Steenberg J, Moller AM. Systematic review of the effects of fascia iliaca compartment block on hip fracture patients before operation. Br J Anaesth. 2018 Jun;120(6):1368-1380. doi: 10.1016/j.bja.2017.12.042. Epub 2018 Apr 5. — View Citation
Wan HY, Li SY, Ji W, Yu B, Jiang N. Fascia Iliaca Compartment Block for Perioperative Pain Management of Geriatric Patients with Hip Fractures: A Systematic Review of Randomized Controlled Trials. Pain Res Manag. 2020 Nov 25;2020:8503963. doi: 10.1155/2020/8503963. eCollection 2020. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-hospital Delirium | Incidence of delirium using Nursing Delirium Screening Scale (NU-DESC) Thai version plus backward counting 30-1. Total Scale 11 ( > or = 2 means delirium). The patient will be assessed once a day in the morning period. | In hospital admission, assess up to 30 days | |
Secondary | Preoperative pain score | Numeric rating scale (0-10; 0=no pain, 10 worst pain imaginable) will be used. The patient will be assessed every 6 hours duration until receiving surgery within 48 hours. | 48 hours after hospital admission | |
Secondary | Post-operative pain score | Numeric rating scale (0-10; 0=no pain, 10 worst pain imaginable) will be used. The patient will be assessed every 6 hours duration postoperatively until 72 hours | Until postoperative 72 hours | |
Secondary | Preoperative morphine consumption | Milligram morphine equivalent | 48 hours after hospital admission | |
Secondary | Postoperative morphine consumption | Milligram morphine equivalent | Until postoperative 72 hours | |
Secondary | Major adverse cardiac events | Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli) | In hospital admission, up to 30 days | |
Secondary | In-hospital morbidities | Incidence of in-hospital morbidities include deep vein thrombosis sepsis, pneumonia, respiratory failure, urinary tract infection, acute kidney injury | In hospital admission, up to 30 days | |
Secondary | Discharge hospital status | Self-care ability to perform the activity of daily living (ADLs) | On hospital discharge day, up to 30 days | |
Secondary | Length of hospital stay | Days of hospital stay | In hospital admission, up to 30 days | |
Secondary | In-hospital mortality rate | Incidence related to all causes of death implant related (implant removal, implant exchange, implant failure,) infection related, bleeding related, non-union fracture, re-fracture | In hospital admission, up to 30 days | |
Secondary | 30 days mortality | Incidence of death | In hospital admission, up to 30 days | |
Secondary | Predict 30-day mortality in hip fracture patient with multiple comorbidities | Charlson Comorbidity Index (CCI) with 19 item-version (adjusted weights for each condition). Higher score of Charlson Comorbidity Index (CCI) is related to higher mortality. CCI score 1-2 = mild, 3-5 scores = moderate, > or = 5 scores = severe. | On admission day |
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