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Completed

NCT Number: NCT06112548

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

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?

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Key information

Conditions

Arthritis Knee Arthritis Arthroplasty Complications Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus university

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

primary unilateral TKA

Procedure

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

Bupivacain

Drug

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

Ketorolac

Drug

1ml of 30mg/ml ketorolac intraoperative periarticular injection

Other names: Toradol

Epinephrine

Drug

0.5ml Adrenaline 1mg/ml intraoperative periarticular injection

Other names: Adrenaline

Paracetamol

Drug

IV Paracetamol [Ofirmev] introduced every 6 hours after surgery

Tramadol

Drug

IV Tramadol [Ultram] introduced when needed after surgery

Primary outcomes

  1. perception of pain - first assessment

    Time frame: measured 12 hours after surgery.

    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.

  2. perception of pain - second assessment

    Time frame: measured 24 hours after surgery.

    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.

  3. perception of pain - third assessment

    Time frame: measured 48 hours after surgery.

    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.

  4. functional status - first assessment

    Time frame: first measurement four weeks 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 function section.

  5. magnitude of disabling pain according to KSS - first assessment

    Time frame: first measurement four weeks 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.

  6. magnitude of disabling pain according to KSS - second assessment

    Time frame: first measurement six months 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.

  7. functional status - second assessment

    Time frame: second measurement six months 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 function section.

  8. estimated total blood loss

    Time frame: measured once 48 hours after surgery.

    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

Secondary outcomes

  1. perioperative complications

    Time frame: if happened within 6 months of surgery

    complications such as Venous thromboembolism VTE, infection, drug side effects ETC

  2. opioids consumption - frequency

    Time frame: measured once 48 hours after surgery.

    the amount of consumed opioids measured by times of application in the close postoperative period

  3. opioids consumption - dose

    Time frame: measured once 48 hours after surgery.

    the amount of consumed opioids measured by the dose used in the close postoperative period

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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