The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA

Pain Clinical Trial

Official title:

The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral Total Knee Arthroplasty: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112548
• Other study ID #: UDMS-Orthopedics-3-2023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: jaber ibrahim, MD PHD
• Phone: 944411241
• Email: drjaberhibrahim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• all patients with end-stage arthritis of the knee going primary unilateral total knee arthroplasty.

Exclusion Criteria:

• inflammatory and secondary arthritis of the knee.
• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee
• Arthroplasty Complications
• Pain

Intervention

Procedure:
• primary unilateral TKA
Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.

Drug:
• 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

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus university	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (13)

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. — View Citation

Doyle DJ, Hendrix JM, Garmon EH. American Society of Anesthesiologists Classification. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	magnitude of disabling pain according to KSS - 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 pain section.	first measurement six months after surgery.
Primary	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.
Primary	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.
Secondary	perioperative complications	complications such as Venous thromboembolism VTE, infection, drug side effects ETC	if happened within 6 months of surgery
Secondary	opioids consumption - frequency	the amount of consumed opioids measured by times of application in the close postoperative period	measured once 48 hours after surgery.
Secondary	opioids consumption - dose	the amount of consumed opioids measured by the dose used in the close postoperative period	measured once 48 hours after surgery.