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

October 27, 2023 updated by: Damascus University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TKA with pain management by multimodal periarticular injection.
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
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
Drug: ketorolac
1ml of 30mg/ml ketorolac intraoperative periarticular injection
Other Names:
  • Toradol
Drug: epinephrine
0.5ml Adrenaline 1mg/ml intraoperative periarticular injection
Other Names:
  • Adrenaline
Drug: Tramadol
IV Tramadol [Ultram] introduced when needed after surgery
Experimental: TKA with pain management by IV/oral analgesics.
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
Primary unilateral total knee arthroplasty with cruciate scarifying cemented DePuy Synthes PFC Sigma prosthesis.
Drug: Tramadol
IV Tramadol [Ultram] introduced when needed after surgery
Drug: Paracetamol
IV Paracetamol [Ofirmev] introduced every 6 hours after surgery
Drug: Ketorolac
IV Ketorolac {Toradol} introduced every 12 hours after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
measured 12 hours after surgery.
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.
measured 24 hours after surgery.
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.
measured 48 hours after surgery.
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.
first measurement four weeks after surgery.
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.
first measurement four weeks after surgery.
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.
first measurement six months after surgery.
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.
second measurement six months after surgery.
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
measured once 48 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative complications
Time Frame: if happened within 6 months of surgery
complications such as Venous thromboembolism VTE, infection, drug side effects ETC
if happened within 6 months of surgery
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
measured once 48 hours after surgery.
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
measured once 48 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Chair: jaber ibrahim, MD PHD, Damascus university - faculty of medicine - department of surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Orthopedics-3-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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