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

Phase 4

• Conditions: Pain Postoperative; Total Knee Anthroplasty; Functional Outcomes

• Registration Number: NCT06800846
• Lead Sponsor: Thammasat University Hospital

Brief 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.

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-23
• Study First Posted: 2025-01-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 50 - 80 yrs of age ASA classification: 1-3 Unilateral TKA

Exclusion Criteria

• Secondary OA knee Previous knee surgery Can't undertaken spinal block and adductor canal block Renal insuf. (Crcl < 30 ml/min) History of convulsive disorder Abnormal liver function BMI > 35 Kg/M2 Allergy to study drugs History of coronary disease Hb < 10 (g/dl) Can't understand 100mm-VAS assessment Refuse to recruit in the study, or refuse follow up Using opioid in 5 days before surgery Unstable vital sign History current VTE Using anti-platelet or anti-coagulation medicine Severe deformity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain scores	at 4, 6 hours and every 6 hours after surgery for 2 days, then daily for 2 weeks after surgery.	Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)

Secondary Outcome Measures

Name	Time	Method
Number of other Events of Morphine side effect	2 weeks after surgery	Itching, rash, constipation, difficult urination, respiratory, etc.
ROM	before surgery and 24, 48hours and 2 weeks after surgery	ROM (degree)
Length of stays in hospital	up to 72 hours	Number of hours the patient stays for surgery
Number of other complication	2 weeks	clinical VTE, wound and skin complication, superficial and deep infection
Morphine consumption	2 weeks	Morphine consumption in hospital 48 hours before discharge and MST as home medication for 2 weeks (MME)
Timed up and go test	at 48 hours and 2 weeks after surgery	start with standing and then walk for 3 meters, then turn back to seat for 3 meters, then sit (report in seconds)
Time to walk	up to 48 hours	hours after surgery of patients at first start walking to the toilet
number of vomit events	at first 48 hours before discharge and after discharge for 2 weeks after surgery	number of vomit events
Operative time	up to 2 hours	duration from start incision to wound closure in TKA procedure (minutes)

Trial Locations

Locations (1)

Thammasat University Hospital; 🇹🇭 Khlong Luang, Pathum Thani, Thailand