NCT06800846

Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection

Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous Multimodal Analgesic Agent Injection Versus Periarticular Injection - A Randomized Control Trial

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Thammasat University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this RCT is to compare analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection. The main question\[s\] it aims to answer are: Does Intraosseous multimodal analgesic cocktail injection have more post-operative analgesic effect than Peri-articular injection in patients who have done TKA (P)? Participants will randomized to intraosseous injection group or peri-articular injection group and will record the 100-mm VAS pain scores for 2 weeks after TKA. Researchers will compare to peri-articular injection group to see pain and functional outcomes after TKA.

Detailed description

Intra-operatively, you will be randomly assigned to receive intraosseous multimodal analgesic agent injection or peri-articular multimodal analgesic agent injection along with other standard medications. In the intraosseous injection group: Participants received combinations of 0.5% bupivacaine 100 mg + 0.1% adrenaline 0.6 mg + Morphine 5mg + Ketorolac 30 mg (totally 22 ml) which divided by 12 ml inject into intramedullary canal before bone plug impaction to close the canal and 10 ml inject into metaphysis of tibia before cementation and implantation. In the peri-articualr injection group: Participants received combinations of the same drug and mix with normal saline solution for totally 75 ml which divided by 25 ml inject into medial gutter and 25 ml inject into lateral gutter before cementation and implantation. And the last 25 ml of multimodal analgesic drugs were injected into quadriceps.

Conditions

• Pain Postoperative
• Total Knee Anthroplasty
• Functional Outcomes

Interventions

Type	Name	Description
PROCEDURE	Intraosseous Morphine	Participants received combinations of 0.5% bupivacaine 100 mg + 0.1% adrenaline 0.6 mg + Morphine 5mg + Ketorolac 30 mg (totally 22 ml) which divided by 12 ml inject into intramedullary canal before bone plug impaction to close the canal and 10 ml inject into metaphysis of tibia before cementation and implantation
PROCEDURE	Periarticular Injection	Participants received combinations of 0.5% bupivacaine 100 mg + 0.1% adrenaline 0.6 mg + Morphine 5mg + Ketorolac 30 mg and mix with normal saline solution for totally 75 ml which divided by 25 ml inject into medial gutter and 25 ml inject into lateral gutter before cementation and implantation. And the last 25 ml of multimodal analgesic drugs were injected into quadriceps.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-05-31
• Completion: 2025-06-30
• First posted: 2025-01-30
• Last updated: 2025-06-04

Locations

1 site across 1 country: Thailand