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

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05325671
• Other study ID #: 65016
• Status: Completed
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2022
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Pain, Post Operative
• Pain, Postoperative

Intervention

Procedure:
• transarticular multimodal drug infiltration
as described previously

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (20)

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 techniqu — View 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. — View 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. — View 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, W — View 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. — View 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 A — View 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. — View 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. — View 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;2021:991459 — View 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 controlle — View 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. — View 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. — View 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 — View 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 — View 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). 201 — View 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. — View 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 Traumato — View 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. — View 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/ — View 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.00000000000 — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale at rest on postoperative day1st and 2nd		1 week
Secondary	total morphine consumption in first 24 hours postoperative period via PCA pump		1 week
Secondary	total morphine consumption in whole postoperative period		1 week
Secondary	length of stay		1 week
Secondary	postoperative complication		1 week