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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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
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.
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand
pain scores
Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)
Time frame: at 4, 6 hours and every 6 hours after surgery for 2 days, then daily for 2 weeks after surgery.
Morphine consumption
Morphine consumption in hospital 48 hours before discharge and MST as home medication for 2 weeks (MME)
Time frame: 2 weeks
number of vomit events
number of vomit events
Time frame: at first 48 hours before discharge and after discharge for 2 weeks after surgery
Number of other Events of Morphine side effect
Itching, rash, constipation, difficult urination, respiratory, etc.
Time frame: 2 weeks after surgery
ROM
ROM (degree)
Time frame: before surgery and 24, 48hours and 2 weeks after surgery
Timed up and go test
start with standing and then walk for 3 meters, then turn back to seat for 3 meters, then sit (report in seconds)
Time frame: at 48 hours and 2 weeks after surgery
Length of stays in hospital
Number of hours the patient stays for surgery
Time frame: up to 72 hours
Time to walk
hours after surgery of patients at first start walking to the toilet
Time frame: up to 48 hours
Operative time
duration from start incision to wound closure in TKA procedure (minutes)
Time frame: up to 2 hours
Number of other complication
clinical VTE, wound and skin complication, superficial and deep infection
Time frame: 2 weeks
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