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

Damascus University

Status

Enrolling

Conditions

Arthritis Knee

Arthroplasty Complications

Pain

Treatments

Drug: Paracetamol

Drug: Tramadol

Drug: Bupivacain

Drug: epinephrine

Drug: ketorolac

Procedure: primary unilateral TKA

Drug: Ketorolac

Study type

Interventional

Funder types

Other

Identifiers

NCT06112548

UDMS-Orthopedics-3-2023

Details and patient eligibility

About

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?

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

TKA with pain management by multimodal periarticular injection.

Experimental group

Description:

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.

Treatment:

Procedure: primary unilateral TKA

Drug: Bupivacain

Drug: epinephrine

Drug: ketorolac

Drug: Tramadol

TKA with pain management by IV/oral analgesics.

Experimental group

Description:

Patients going TKA and getting a standard pain control regime of IV opioids when needed, IV ketorolac, and IV/oral paracetamol.

Treatment:

Procedure: primary unilateral TKA