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

Last updated: March 17, 2026
Sponsor: Damascus University
Overall Status: Completed

Phase

N/A

Condition

Pain

Joint Injuries

Treatment

primary unilateral TKA

Bupivacain

Tramadol

Clinical Study ID

NCT06112548
UDMS-Orthopedics-3-2023
  • Ages 50-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 ofaddiction.

  • BMI less than 20 and more than 35.

  • patients with intra-operative complications that would affect the outcomesmeasurement.

  • 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.

Study Design

Total Participants: 80
Treatment Group(s): 7
Primary Treatment: primary unilateral TKA
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Damascus university

    Damascus,
    Syria

    Site Not Available

  • Damascus university

    Damascus,
    Syrian Arab Republic

    Active - Recruiting

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