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The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture

Primary Purpose

Hip Fractures, Pain, Acute, Hip Fracture Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Post-admission FICB
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who are aged ≥65 , <85 years old and diagnose hip fracture in 8 hospitals Planed for fast-track hip surgery Isolated acute hip fracture Pain on admission during movement ≥ 4 (moderate pain) Exclusion Criteria: refusal to participate the study 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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Post-admission FICB

Only preoperative FICB

Arm Description

Post-admission FICB, drug 0.33% bupivacaine 30 ml + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid.

No post-admission FICB + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Preoperative morphine consumption
Milligram morphine equivalent
Postoperative morphine consumption
Milligram morphine equivalent
Major adverse cardiac events
Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli)
In-hospital morbidities
Incidence of in-hospital morbidities include deep vein thrombosis sepsis, pneumonia, respiratory failure, urinary tract infection, acute kidney injury
Discharge hospital status
Self-care ability to perform the activity of daily living (ADLs)
Length of hospital stay
Days of hospital stay
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
30 days mortality
Incidence of death
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.

Full Information

First Posted
March 29, 2023
Last Updated
May 4, 2023
Sponsor
Mahidol University
Collaborators
Ministry of Health, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT05857462
Brief Title
The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Ministry of Health, Thailand

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
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).
Detailed Description
Population: elderly patients age ≥ 65 years old, diagnosed with an isolated acute hip fracture within 7 days and plan to receive fast-track hip fracture. Statistic analysis plan surgery within 48 hours after hospital admission. Study population: elderly isolated hip fracture patients who are admitted in those 8 hospitals centers in Thailand and have moderate pain or higher than moderate pain during movement since hospital admission. Sample size : 210 patients per group (drop out 10%) total 420 patients Statistical analysis: SPSS will be used for study analysis. The category variables will be present as number and percentage, and chi-square or fisher exact test will be used to compare between the groups.The continuous variables will be tested the distribution, data presentation will be mean and standard deviation (SD) for normal distribution while median and interquartile rang (IQR) for non-normal distribution. Student t test or Wilcoxson rank some test will be used as appropriate to test for different between the group. And p value less than 0.05 will be considered statically significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Pain, Acute, Hip Fracture Surgery, Delirium in Old Age, Pain Intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-admission FICB
Arm Type
Experimental
Arm Description
Post-admission FICB, drug 0.33% bupivacaine 30 ml + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid.
Arm Title
Only preoperative FICB
Arm Type
No Intervention
Arm Description
No post-admission FICB + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid.
Intervention Type
Procedure
Intervention Name(s)
Post-admission FICB
Intervention Description
Post-admission supra-inguinal FICB in hip fracture patient with 0.33% bupivacaine 30 ml
Primary Outcome Measure Information:
Title
In-hospital Delirium
Description
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.
Time Frame
In hospital admission, assess up to 30 days
Secondary Outcome Measure Information:
Title
Preoperative pain score
Description
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.
Time Frame
48 hours after hospital admission
Title
Post-operative pain score
Description
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
Time Frame
Until postoperative 72 hours
Title
Preoperative morphine consumption
Description
Milligram morphine equivalent
Time Frame
48 hours after hospital admission
Title
Postoperative morphine consumption
Description
Milligram morphine equivalent
Time Frame
Until postoperative 72 hours
Title
Major adverse cardiac events
Description
Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli)
Time Frame
In hospital admission, up to 30 days
Title
In-hospital morbidities
Description
Incidence of in-hospital morbidities include deep vein thrombosis sepsis, pneumonia, respiratory failure, urinary tract infection, acute kidney injury
Time Frame
In hospital admission, up to 30 days
Title
Discharge hospital status
Description
Self-care ability to perform the activity of daily living (ADLs)
Time Frame
On hospital discharge day, up to 30 days
Title
Length of hospital stay
Description
Days of hospital stay
Time Frame
In hospital admission, up to 30 days
Title
In-hospital mortality rate
Description
Incidence related to all causes of death implant related (implant removal, implant exchange, implant failure,) infection related, bleeding related, non-union fracture, re-fracture
Time Frame
In hospital admission, up to 30 days
Title
30 days mortality
Description
Incidence of death
Time Frame
In hospital admission, up to 30 days
Title
Predict 30-day mortality in hip fracture patient with multiple comorbidities
Description
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.
Time Frame
On admission day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are aged ≥65 , <85 years old and diagnose hip fracture in 8 hospitals Planed for fast-track hip surgery Isolated acute hip fracture Pain on admission during movement ≥ 4 (moderate pain) Exclusion Criteria: refusal to participate the study 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suwimon Tangwiwat, MD
Phone
66816456167
Email
stangwiwat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, M.D
Phone
(66)81-645-6167
Email
stangwiwat@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nichapat Thongkaew
Phone
6624197978
Ext
501
Email
nokaeko@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20120672
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.
Results Reference
background
PubMed Identifier
25775733
Citation
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.
Results Reference
background
PubMed Identifier
26529819
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.
Results Reference
background
PubMed Identifier
28851773
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.
Results Reference
background
PubMed Identifier
31122228
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.
Results Reference
background
PubMed Identifier
32618917
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.
Results Reference
background
PubMed Identifier
27909117
Citation
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.
Results Reference
background
PubMed Identifier
29183076
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.
Results Reference
background
PubMed Identifier
33639957
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.
Results Reference
background
PubMed Identifier
29793602
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.
Results Reference
background
PubMed Identifier
31274264
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.
Results Reference
background
PubMed Identifier
33294087
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.
Results Reference
background
PubMed Identifier
31522217
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.
Results Reference
background
PubMed Identifier
17413915
Citation
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.
Results Reference
background
PubMed Identifier
26759680
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.
Results Reference
background
PubMed Identifier
25068412
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.
Results Reference
background
PubMed Identifier
29576642
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.
Results Reference
background
PubMed Identifier
30544447
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.
Results Reference
background
PubMed Identifier
26125194
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.
Results Reference
background
PubMed Identifier
25004177
Citation
Lawlor PG, Bush SH. Delirium diagnosis, screening and management. Curr Opin Support Palliat Care. 2014 Sep;8(3):286-95. doi: 10.1097/SPC.0000000000000062.
Results Reference
background
PubMed Identifier
34366425
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.
Results Reference
background
PubMed Identifier
28262269
Citation
Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) Investigators. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial. Lancet. 2017 Apr 15;389(10078):1519-1527. doi: 10.1016/S0140-6736(17)30066-1. Epub 2017 Mar 3.
Results Reference
background
PubMed Identifier
19690943
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.
Results Reference
background
Links:
URL
http://www.nice.org.uk/guidance/cg124
Description
National Institute for Health and Care Excellence. Clinical guideline: Hip fracture: management 2011.

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The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture

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