Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial
Primary Purpose
Pain, Post Operative, Arthroplasty Complications
Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
transarticular multimodal drug infiltration
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Post Operative focused on measuring total hip arthroplasty, transarticular multimodal drug infiltration, periarticular multimodal drug infiltration
Eligibility Criteria
Inclusion Criteria:
- patient who would go on cemented and cementless THA
- age 45-60 years of age
- voluntary decision exclusion criteria
- bilateral THA
- revision surgery
- history of pelvic and hip surgery previously
- allergy to medication in protocol
- CKD stage 4-5, chronic liver disease with Child Pugh B or C
- pregnancy
- history of hip injection
- U/D
- hypercoagulable state
- abnormal laboratory coagulation study as INR > 1.4 or aPTT > 1.4
- abnormal platelet function
- thrombocytopenia
- PE , DVT, ischemic stroke, CAD/ischemic heart disease
- use of anticoagulant or hormonal usage
- anesthesia by general anesthesia or additional nerve block
- can not understand PCA usage
- use postopertive wound drainage
Sites / Locations
- Rajavithi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
transarticular multimodal drug infiltration
periarticular multimodal drug infiltration
Arm Description
infiltration the mixture into intraarticular by catheter guided approach
3 location of infiltration hip capsule gluteus medius and short external rotator gluteus maximus
Outcomes
Primary Outcome Measures
Visual analogue scale at rest on postoperative day1st and 2nd
Secondary Outcome Measures
total morphine consumption in first 24 hours postoperative period via PCA pump
total morphine consumption in whole postoperative period
length of stay
postoperative complication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05325671
Brief Title
Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial
Official Title
Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 5, 2022 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research aim to improve postoperative outcome in total hip arthroplasty(THA) by using local mixture infiltration as bupivacaine + NSAID + epinephrine + tranxemic acid. In the present time these mixture components has shown to improve THA outcome by aspect of postoperative pain control, postoperative opioid consumption, postoperative bleeding, LOS and postoperative rehabilitation without increasing complication but the accuracy of infiltration technique which gives the best outcome has not been yet discovered.Recently study by Hashimoto et al has risen that these technique can be administrated by both periarticular and intra-articular approach.By considering the complexity of human anatomy around the hip tissue we assume that the intra-articular(transarticular) may given equivalence (may be better) outcome with lowering procedural related complication comparing to periarticular infiltration approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative, Arthroplasty Complications
Keywords
total hip arthroplasty, transarticular multimodal drug infiltration, periarticular multimodal drug infiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transarticular multimodal drug infiltration
Arm Type
Experimental
Arm Description
infiltration the mixture into intraarticular by catheter guided approach
Arm Title
periarticular multimodal drug infiltration
Arm Type
Active Comparator
Arm Description
3 location of infiltration
hip capsule
gluteus medius and short external rotator
gluteus maximus
Intervention Type
Procedure
Intervention Name(s)
transarticular multimodal drug infiltration
Intervention Description
as described previously
Primary Outcome Measure Information:
Title
Visual analogue scale at rest on postoperative day1st and 2nd
Time Frame
1 week
Secondary Outcome Measure Information:
Title
total morphine consumption in first 24 hours postoperative period via PCA pump
Time Frame
1 week
Title
total morphine consumption in whole postoperative period
Time Frame
1 week
Title
length of stay
Time Frame
1 week
Title
postoperative complication
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patient who would go on cemented and cementless THA
age 45-60 years of age
voluntary decision exclusion criteria
bilateral THA
revision surgery
history of pelvic and hip surgery previously
allergy to medication in protocol
CKD stage 4-5, chronic liver disease with Child Pugh B or C
pregnancy
history of hip injection
U/D
hypercoagulable state
abnormal laboratory coagulation study as INR > 1.4 or aPTT > 1.4
abnormal platelet function
thrombocytopenia
PE , DVT, ischemic stroke, CAD/ischemic heart disease
use of anticoagulant or hormonal usage
anesthesia by general anesthesia or additional nerve block
can not understand PCA usage
use postopertive wound drainage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peerapon Nantapong, MD
Phone
+6695-6800444
Email
peeraponthong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thakrit Chompoosang, MD
Phone
+6684-6461916
Email
tk_ortho@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peerapon Nantapong, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thakrit Chompoosang, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajavithi Hospital
Phone
+6695-6800444
Email
peeraponthong@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29939641
Citation
Varacallo M, Luo TD, Johanson NA. Total Hip Arthroplasty Techniques. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507864/
Results Reference
result
PubMed Identifier
28870302
Citation
Gaffney CJ, Pelt CE, Gililland JM, Peters CL. Perioperative Pain Management in Hip and Knee Arthroplasty. Orthop Clin North Am. 2017 Oct;48(4):407-419. doi: 10.1016/j.ocl.2017.05.001. Epub 2017 Jun 29.
Results Reference
result
PubMed Identifier
26827847
Citation
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
Results Reference
result
PubMed Identifier
17464604
Citation
Andersen KV, Pfeiffer-Jensen M, Haraldsted V, Soballe K. Reduced hospital stay and narcotic consumption, and improved mobilization with local and intraarticular infiltration after hip arthroplasty: a randomized clinical trial of an intraarticular technique versus epidural infusion in 80 patients. Acta Orthop. 2007 Apr;78(2):180-6. doi: 10.1080/17453670710013654.
Results Reference
result
PubMed Identifier
20020333
Citation
Busch CA, Whitehouse MR, Shore BJ, MacDonald SJ, McCalden RW, Bourne RB. The efficacy of periarticular multimodal drug infiltration in total hip arthroplasty. Clin Orthop Relat Res. 2010 Aug;468(8):2152-9. doi: 10.1007/s11999-009-1198-7. Epub 2009 Dec 18.
Results Reference
result
PubMed Identifier
17823012
Citation
Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
Results Reference
result
PubMed Identifier
32993338
Citation
Kurosaka K, Tsukada S, Ogawa H, Nishino M, Nakayama T, Yoshiya S, Hirasawa N. Addition of corticosteroid to periarticular injections reduces postoperative pain following total hip arthroplasty under general anaesthesia: a double-blind randomized controlled trial. Bone Joint J. 2020 Oct;102-B(10):1297-1302. doi: 10.1302/0301-620X.102B10.BJJ-2020-0428.R1.
Results Reference
result
PubMed Identifier
32782868
Citation
Tsinaslanidis G, Tsinaslanidis P, Mahajan RH. Perioperative Pain Management in Patients Undergoing Total Hip Arthroplasty: Where Do We Currently Stand? Cureus. 2020 Jul 7;12(7):e9049. doi: 10.7759/cureus.9049.
Results Reference
result
PubMed Identifier
22822998
Citation
Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.
Results Reference
result
PubMed Identifier
30122981
Citation
El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.
Results Reference
result
PubMed Identifier
30146350
Citation
Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic Acid Use in Total Joint Arthroplasty: The Clinical Practice Guidelines Endorsed by the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. J Arthroplasty. 2018 Oct;33(10):3065-3069. doi: 10.1016/j.arth.2018.08.002. Epub 2018 Aug 7. No abstract available.
Results Reference
result
PubMed Identifier
29794747
Citation
Stoicea N, Moran K, Mahmoud AR, Glassman A, Ellis T, Ryan J, Granger J, Joseph N, Salon N, Ackermann W, Rogers B, Niermeyer W, Bergese SD. Tranexamic acid use during total hip arthroplasty: A single center retrospective analysis. Medicine (Baltimore). 2018 May;97(21):e10720. doi: 10.1097/MD.0000000000010720.
Results Reference
result
PubMed Identifier
21196541
Citation
Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984.
Results Reference
result
PubMed Identifier
31570210
Citation
Qiu J, Sun X, Zhang W, Ke X, Yang G, Zhang L. Effect of topical tranexamic acid in total hip arthroplasty patients who receive continuous aspirin for prevention of cardiovascular or cerebrovascular events: A prospective randomized study. Orthop Traumatol Surg Res. 2019 Nov;105(7):1327-1332. doi: 10.1016/j.otsr.2019.06.018. Epub 2019 Sep 27.
Results Reference
result
PubMed Identifier
31153361
Citation
Ma HH, Chou TA, Tsai SW, Chen CF, Wu PK, Chen WM. The efficacy of intraoperative periarticular injection in Total hip arthroplasty: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019 Jun 1;20(1):269. doi: 10.1186/s12891-019-2628-7.
Results Reference
result
PubMed Identifier
28328836
Citation
Wang Y, Gao F, Sun W, Wang B, Guo W, Li Z. The efficacy of periarticular drug infiltration for postoperative pain after total hip arthroplasty: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Mar;96(12):e6401. doi: 10.1097/MD.0000000000006401.
Results Reference
result
PubMed Identifier
34349850
Citation
Hashimoto A, Sonohata M, Kawaguchi A, Kii S, Hirata H, Mawatari M. Comparison of the Effect of Different Local Analgesia Administration Techniques in Total Hip Arthroplasty: A Retrospective Comparative Cohort Study. Pain Res Manag. 2021 Jul 24;2021:9914590. doi: 10.1155/2021/9914590. eCollection 2021.
Results Reference
result
PubMed Identifier
21936146
Citation
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
Results Reference
result
PubMed Identifier
31359178
Citation
Tammachote N, Raphiphan R, Kanitnate S. High-dose (3 g) topical tranexamic acid has higher potency in reducing blood loss after total knee arthroplasty compared with low dose (500 mg): a double-blind randomized controlled trial. Eur J Orthop Surg Traumatol. 2019 Dec;29(8):1729-1735. doi: 10.1007/s00590-019-02515-2. Epub 2019 Jul 29.
Results Reference
result
PubMed Identifier
26521781
Citation
Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041.
Results Reference
result
Learn more about this trial
Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial
We'll reach out to this number within 24 hrs