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This interventional study aims to compare the effectiveness of local multimodal drug periarticular injection in TKA patients with the standard pain control regime that includes opioids, NSAIDs, and other analgesics.
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?
The best pain control regime following TKA is controversial. While opioids have an excellent analgesic effect, they also have many side effects. The investigators are conducting a randomized controlled trial to compare the severity of pain following primary unilateral TKA when multimodal drug periarticular injunction is used with the standard pain control regime. The investigators will enroll patients undergoing primary unilateral TKA and randomly allocate them into one treatment group. The first will undergo the procedure with periarticular injection before the closure is composed 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, and the second will go standard TKA with pain control using opioids, NSAIDS, and paracetamol. The severity of postoperative pain is the primary outcome studied, as well as preoperative complications and any drug side effects, the data will be collected by a fellow researcher who is blinded to the interventions, and the patients will be blinded too. Randomization will be done by a research fellow who is not involved in patient treatment or care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA with pain management by multimodal periarticular injection. | Experimental | 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. |
|
| TKA with pain management by IV/oral analgesics. | Experimental | Patients going TKA and getting a standard pain control regime of IV opioids when needed, IV ketorolac, and IV/oral paracetamol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| primary unilateral TKA | Procedure | Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| perception of pain - first assessment | The severity of knee pain in the short postoperative period. As stated by the patient, on a scale of 0 to 10, 0 resents no pain at all, and 10 is the worst pain the participant can imagine. | measured 12 hours after surgery. |
| perception of pain - second assessment | The severity of knee pain in the short postoperative period. As stated by the patient, on a scale of 0 to 10, 0 resents no pain at all, and 10 is the worst pain the participant can imagine. | measured 24 hours after surgery. |
| perception of pain - third assessment | The severity of knee pain in the short postoperative period. As stated by the patient, on a scale of 0 to 10, 0 resents no pain at all, and 10 is the worst pain the participant can imagine. | measured 48 hours after surgery. |
| functional status - first assessment | a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. here, the investigator assesses the function section. | first measurement four weeks after surgery. |
| magnitude of disabling pain according to KSS - first assessment | a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100, with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. Here the investigator assesses the pain section. | first measurement four weeks after surgery. |
| magnitude of disabling pain according to KSS - second assessment |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative complications | complications such as Venous thromboembolism VTE, infection, drug side effects ETC | if happened within 6 months of surgery |
| opioids consumption - frequency | the amount of consumed opioids measured by times of application in the close postoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jaber ibrahim, MD PHD | Damascus university - faculty of medicine - department of surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damascus university | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15995115 | Background | 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. | |
| 28856350 | Background | 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. |
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| Bupivacain | Drug | low body weight (0.50%, 20cc) intraoperative periarticular injection |
|
| ketorolac | Drug | 1ml of 30mg/ml ketorolac intraoperative periarticular injection |
|
|
| epinephrine | Drug | 0.5ml Adrenaline 1mg/ml intraoperative periarticular injection |
|
|
| Paracetamol | Drug | IV Paracetamol [Ofirmev] introduced every 6 hours after surgery |
|
| Ketorolac | Drug | IV Ketorolac {Toradol} introduced every 12 hours after surgery. |
|
| Tramadol | Drug | IV Tramadol [Ultram] introduced when needed after surgery |
|
a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100, with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. Here the investigator assesses the pain section. |
| first measurement six months after surgery. |
| functional status - second assessment | a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. here, the investigator assesses the function section. | second measurement six months after surgery. |
| estimated total blood loss | the total amount of lost blood in the perioperative period and will be calculated using the Gross formula which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value | measured once 48 hours after surgery. |
| measured once 48 hours after surgery. |
| opioids consumption - dose | the amount of consumed opioids measured by the dose used in the close postoperative period | measured once 48 hours after surgery. |
| 19763716 | Background | 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. |
| 14622770 | Background | 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. |
| 2367246 | Background | 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. |
| 1977542 | Background | 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. |
| 19680735 | Background | 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. |
| 2478049 | Background | 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. |
| 8363072 | Background | 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. |
| 1952132 | Background | 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. |
| 24641895 | Background | 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. |
| 28722969 | Background | Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/ |
| 16320034 | Background | 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. |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D004837 | Epinephrine |
| D000082 | Acetaminophen |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000083 | Acetanilides |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |
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