The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA
NCT ID: NCT06112548
Last Updated: 2024-05-02
Study Results
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-03-01
2025-11-30
Brief Summary
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The main questions The investigators strive to answer are:
Is there a significant difference in the severity of pain and functional outcomes when applying periarticular injections? Are there any increased complications when applying the periarticular injections?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TKA with pain management by multimodal periarticular injection.
Patients going TKA and getting an injection of a mixture of 20ml of low body weight bupivacaine 5mg/ml plus 1ml of ketorolac 30mg/ml plus 0.5ml adrenaline 1mg/ml injected in medial and lateral retinaculum, medial and lateral collateral ligaments, quadriceps and patellar tendon, joint capsule, subcutaneous fat before closure.
primary unilateral TKA
Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.
Bupivacain
low body weight (0.50%, 20cc) intraoperative periarticular injection
ketorolac
1ml of 30mg/ml ketorolac intraoperative periarticular injection
epinephrine
0.5ml Adrenaline 1mg/ml intraoperative periarticular injection
Tramadol
IV Tramadol \[Ultram\] introduced when needed after surgery
TKA with pain management by IV/oral analgesics.
Patients going TKA and getting a standard pain control regime of IV opioids when needed, IV ketorolac, and IV/oral paracetamol.
primary unilateral TKA
Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.
Paracetamol
IV Paracetamol \[Ofirmev\] introduced every 6 hours after surgery
Ketorolac
IV Ketorolac {Toradol} introduced every 12 hours after surgery.
Tramadol
IV Tramadol \[Ultram\] introduced when needed after surgery
Interventions
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primary unilateral TKA
Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.
Bupivacain
low body weight (0.50%, 20cc) intraoperative periarticular injection
ketorolac
1ml of 30mg/ml ketorolac intraoperative periarticular injection
epinephrine
0.5ml Adrenaline 1mg/ml intraoperative periarticular injection
Paracetamol
IV Paracetamol \[Ofirmev\] introduced every 6 hours after surgery
Ketorolac
IV Ketorolac {Toradol} introduced every 12 hours after surgery.
Tramadol
IV Tramadol \[Ultram\] introduced when needed after surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who are allergic to one or more of the drugs used in the injections.
* Patients who are already taking opioids for whatever reason or have a history of addiction.
* BMI less than 20 and more than 35.
* patients with intra-operative complications that would affect the outcomes measurement.
* Patients who are going through complex primary or revision TKA.
* Pregnancy, renal or liver failure.
* Patients who are classified as grade 3 or more according to ASA.
50 Years
85 Years
ALL
Yes
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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jaber ibrahim, MD PHD
Role: STUDY_CHAIR
Damascus university - faculty of medicine - department of surgery
Locations
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Damascus university
Damascus, , Syria
Countries
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Central Contacts
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Facility Contacts
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References
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Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005 Jul;87(7):1487-97. doi: 10.2106/JBJS.D.02441.
Hadley S, Day M, Schwarzkopf R, Smith A, Slover J, Zuckerman J. Is Simultaneous Bilateral Total Knee Arthroplasty (BTKA) as Safe as Staged BTKA? Am J Orthop (Belle Mead NJ). 2017 Jul/Aug;46(4):E224-E229.
Lavernia CJ, Alcerro JC, Rossi MD. Fear in arthroplasty surgery: the role of race. Clin Orthop Relat Res. 2010 Feb;468(2):547-54. doi: 10.1007/s11999-009-1101-6. Epub 2009 Sep 18.
Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
Shoji H, Solomonow M, Yoshino S, D'Ambrosia R, Dabezies E. Factors affecting postoperative flexion in total knee arthroplasty. Orthopedics. 1990 Jun;13(6):643-9. doi: 10.3928/0147-7447-19900601-08.
Mahoney OM, Noble PC, Davidson J, Tullos HS. The effect of continuous epidural analgesia on postoperative pain, rehabilitation, and duration of hospitalization in total knee arthroplasty. Clin Orthop Relat Res. 1990 Nov;(260):30-7.
Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
Sinatra R, Chung KS, Silverman DG, Brull SJ, Chung J, Harrison DM, Donielson D, Weinstock A. An evaluation of morphine and oxymorphone administered via patient-controlled analgesia (PCA) or PCA plus basal infusion in postcesarean-delivery patients. Anesthesiology. 1989 Oct;71(4):502-7. doi: 10.1097/00000542-198910000-00005.
Allen GC, St Amand MA, Lui AC, Johnson DH, Lindsay MP. Postarthroscopy analgesia with intraarticular bupivacaine/morphine. A randomized clinical trial. Anesthesiology. 1993 Sep;79(3):475-80. doi: 10.1097/00000542-199309000-00010.
Smith I, Van Hemelrijck J, White PF, Shively R. Effects of local anesthesia on recovery after outpatient arthroscopy. Anesth Analg. 1991 Nov;73(5):536-9.
Lonner J. Role of liposomal bupivacaine in pain management after total joint arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):37-41. doi: 10.3113/jsoa.2014.0037.
Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
Other Identifiers
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UDMS-Orthopedics-3-2023
Identifier Type: -
Identifier Source: org_study_id
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