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

NCT06112548 | Completed DMC

• 1 other identifier: UDMS-Orthopedics-3-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Arthritis Knee; Pain; Arthroplasty Complications

Keywords

total knee arthroplasty; arthritis; pain; injection

Outcome Measures

Primary Outcomes (8)

• 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

  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.

Secondary Outcomes (3)

• perioperative complications

  if happened within 6 months of surgery

• opioids consumption - frequency

  measured once 48 hours after surgery.

• opioids consumption - dose

  measured once 48 hours after surgery.

Study Arms (2)

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.

Procedure: primary unilateral TKA; Drug: Bupivacain; Drug: ketorolac; Drug: epinephrine; Drug: Tramadol

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.

Procedure: primary unilateral TKA; Drug: Paracetamol; Drug: Ketorolac; Drug: Tramadol

Interventions

primary unilateral TKA PROCEDURE

Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.

TKA with pain management by IV/oral analgesics.; TKA with pain management by multimodal periarticular injection.

Bupivacain DRUG

low body weight (0.50%, 20cc) intraoperative periarticular injection

TKA with pain management by multimodal periarticular injection.

Ketorolac DRUG

1ml of 30mg/ml ketorolac intraoperative periarticular injection

Also known as: Toradol

TKA with pain management by multimodal periarticular injection.

epinephrine DRUG

0.5ml Adrenaline 1mg/ml intraoperative periarticular injection

Also known as: Adrenaline

TKA with pain management by multimodal periarticular injection.

Paracetamol DRUG

IV Paracetamol \[Ofirmev\] introduced every 6 hours after surgery

TKA with pain management by IV/oral analgesics.

Tramadol DRUG

IV Tramadol \[Ultram\] introduced when needed after surgery

TKA with pain management by IV/oral analgesics.; TKA with pain management by multimodal periarticular injection.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus university

Damascus, Syria

Location

Related Publications (13)

• 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.

  PMID: 15995115 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.

  PMID: 28856350 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.

  PMID: 19763716 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.

  PMID: 14622770 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.

  PMID: 2367246 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.

  PMID: 1977542 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.

  PMID: 19680735 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.

  PMID: 2478049 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.

  PMID: 8363072 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.

  PMID: 1952132 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.

  PMID: 24641895 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/

  PMID: 28722969 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.

  PMID: 16320034 BACKGROUND

MeSH Terms

Conditions

Pain; Arthritis

Interventions

Bupivacaine; Ketorolac; Ketorolac Tromethamine; Epinephrine; Acetaminophen; Tramadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• jaber ibrahim, MD PHD

  Damascus university - faculty of medicine - department of surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: November 1, 2023
• Study Start: March 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 30, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)