Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120, Thailand
NCT Number: NCT06800846
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Phase 4
Khlong Luang, Changwat Pathum Thani, 12120, Thailand
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: intraosseous 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.
Other names: peri-articular injection
Time frame: 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)
Time frame: 2 weeks
Morphine consumption in hospital 48 hours before discharge and MST as home medication for 2 weeks (MME)
Time frame: at first 48 hours before discharge and after discharge for 2 weeks after surgery
number of vomit events
Time frame: 2 weeks after surgery
Itching, rash, constipation, difficult urination, respiratory, etc.
Time frame: before surgery and 24, 48hours and 2 weeks after surgery
ROM (degree)
Time frame: 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 frame: up to 72 hours
Number of hours the patient stays for surgery
Time frame: up to 48 hours
hours after surgery of patients at first start walking to the toilet
Time frame: up to 2 hours
duration from start incision to wound closure in TKA procedure (minutes)
Time frame: 2 weeks
clinical VTE, wound and skin complication, superficial and deep infection
Thammasat University Hospital
Other
Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous Multimodal Analgesic Agent Injection Versus Periarticular Injection - A Randomized Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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