Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial

NCT ID: NCT05325671

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Post Operative Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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transarticular multimodal drug infiltration

infiltration the mixture into intraarticular by catheter guided approach

Group Type EXPERIMENTAL

transarticular multimodal drug infiltration

Intervention Type PROCEDURE

as described previously

periarticular multimodal drug infiltration

3 location of infiltration

1. hip capsule
2. gluteus medius and short external rotator
3. gluteus maximus

Group Type ACTIVE_COMPARATOR

transarticular multimodal drug infiltration

Intervention Type PROCEDURE

as described previously

Interventions

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transarticular multimodal drug infiltration

as described previously

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patient who would go on cemented and cementless THA
* age 45-60 years of age

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peerapon Nantapong, MD

Role: STUDY_DIRECTOR

Department of Medical Services Ministry of Public Health of Thailand

Thakrit Chompoosang, MD

Role: STUDY_CHAIR

Department of Medical Services Ministry of Public Health of Thailand

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Varacallo MA, Luo TD, Johanson NA. Total Hip Arthroplasty Techniques. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507864/

Reference Type RESULT
PMID: 29939641 (View on PubMed)

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.

Reference Type RESULT
PMID: 28870302 (View on PubMed)

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.

Reference Type RESULT
PMID: 26827847 (View on PubMed)

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.

Reference Type RESULT
PMID: 17464604 (View on PubMed)

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.

Reference Type RESULT
PMID: 20020333 (View on PubMed)

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.

Reference Type RESULT
PMID: 17823012 (View on PubMed)

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.

Reference Type RESULT
PMID: 32993338 (View on PubMed)

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.

Reference Type RESULT
PMID: 32782868 (View on PubMed)

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.

Reference Type RESULT
PMID: 22822998 (View on PubMed)

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.

Reference Type RESULT
PMID: 30122981 (View on PubMed)

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.

Reference Type RESULT
PMID: 30146350 (View on PubMed)

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.

Reference Type RESULT
PMID: 29794747 (View on PubMed)

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.

Reference Type RESULT
PMID: 21196541 (View on PubMed)

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.

Reference Type RESULT
PMID: 31570210 (View on PubMed)

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.

Reference Type RESULT
PMID: 31153361 (View on PubMed)

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.

Reference Type RESULT
PMID: 28328836 (View on PubMed)

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.

Reference Type RESULT
PMID: 34349850 (View on PubMed)

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

Reference Type RESULT
PMID: 21936146 (View on PubMed)

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.

Reference Type RESULT
PMID: 31359178 (View on PubMed)

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.

Reference Type RESULT
PMID: 26521781 (View on PubMed)

Other Identifiers

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65016

Identifier Type: -

Identifier Source: org_study_id

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