NCT06112548

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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?

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.

Conditions

• Arthritis Knee
• Pain
• Arthroplasty Complications

Interventions

Type	Name	Description
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
DRUG	epinephrine	0.5ml Adrenaline 1mg/ml intraoperative periarticular injection
DRUG	Paracetamol	IV Paracetamol \[Ofirmev\] introduced every 6 hours after surgery
DRUG	Ketorolac	IV Ketorolac {Toradol} introduced every 12 hours after surgery.
DRUG	Tramadol	IV Tramadol \[Ultram\] introduced when needed after surgery

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-11-01
• Completion: 2025-11-30
• First posted: 2023-11-01
• Last updated: 2026-03-19

Locations

1 site across 1 country: Syria