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Pain, Post OperativeNCT05325671

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

A study testing transarticular multimodal drug infiltration in people with Pain, Post Operative and Arthroplasty Complications, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 60 yearsHealthy volunteers can take part
What is being tested?
transarticular multimodal drug infiltration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteThailand
Study dates
5 Apr 2022to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Rajavithi Hospital

    Bangkok

Other trials in Thailand

About this study

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.

Being tested
transarticular multimodal drug infiltration
Keywords
total hip arthroplasty, transarticular multimodal drug infiltration, periarticular multimodal drug infiltration
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transarticular multimodal drug infiltrationProcedure or surgery

    as described previously

Study groups in NCT05325671
Study groupRoleWhat they receive
transarticular multimodal drug infiltrationExperimentalinfiltration the mixture into intraarticular by catheter guided approach
Receives: Procedure: transarticular multimodal drug infiltration
periarticular multimodal drug infiltrationActive comparator3 location of infiltration 1. hip capsule 2. gluteus medius and short external rotator 3. gluteus maximus
Receives: Procedure: transarticular multimodal drug infiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue scale at rest on postoperative day1st and 2nd

    Measured: 1 week

Secondary outcomes (4)

  1. total morphine consumption in first 24 hours postoperative period via PCA pump

    Measured: 1 week

  2. total morphine consumption in whole postoperative period

    Measured: 1 week

  3. length of stay

    Measured: 1 week

  4. postoperative complication

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study start5 Apr 2022
  3. Primary completion30 Sep 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325671
Sponsor's protocol ID
65016
Status last verified
Apr 2022
First submitted
5 Apr 2022
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Varacallo MA, Luo TD, Johanson NA. Total Hip Arthroplasty Techniques. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507864/

    PubMed 29939641

  • 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.

    PubMed 28870302

  • 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.

    PubMed 26827847

  • 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.

    PubMed 17464604

  • 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.

    PubMed 20020333

  • 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.

    PubMed 17823012

  • 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.

    PubMed 32993338

  • 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.

    PubMed 32782868

  • 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.

    PubMed 22822998

  • 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.

    PubMed 30122981

  • 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.

    PubMed 30146350

  • 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.

    PubMed 29794747

  • 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.

    PubMed 21196541

  • 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.

    PubMed 31570210

  • 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.

    PubMed 31153361

Questions about this trial

What is this clinical trial studying?

A study testing transarticular multimodal drug infiltration in people with Pain, Post Operative and Arthroplasty Complications, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale at rest on postoperative day1st and 2nd (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05325671, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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