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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraosseous multimodal analgesia injection | Experimental | 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 |
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| peri-articular multimodal analgesia injection | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous Morphine | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pain scores | Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst) | at 4, 6 hours and every 6 hours after surgery for 2 days, then daily for 2 weeks after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | Morphine consumption in hospital 48 hours before discharge and MST as home medication for 2 weeks (MME) | 2 weeks |
| number of vomit events | number of vomit events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University Hospital | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37399631 | Result | McNamara CA, Laurita J, Lambert BS, Sullivan TC, Clyburn TA, Incavo SJ, Park KJ. A multimodal intraosseous infusion of morphine and ketorolac decreases early postoperative pain and opioid consumption following total knee arthroplasty. Knee. 2023 Aug;43:129-135. doi: 10.1016/j.knee.2023.06.002. Epub 2023 Jul 1. | |
| 23850410 | Result |
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| Periarticular Injection | Procedure | 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. |
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| 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. | 2 weeks after surgery |
| ROM | ROM (degree) | 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) | at 48 hours and 2 weeks after surgery |
| Length of stays in hospital | Number of hours the patient stays for surgery | up to 72 hours |
| Time to walk | hours after surgery of patients at first start walking to the toilet | up to 48 hours |
| Operative time | duration from start incision to wound closure in TKA procedure (minutes) | up to 2 hours |
| Number of other complication | clinical VTE, wound and skin complication, superficial and deep infection | 2 weeks |
| Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11. |
| 35272897 | Result | Brozovich AA, Incavo SJ, Lambert BS, Sullivan TC, Wininger AE, Clyburn TA, Taraballi F, Park KJ. Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Jun;37(6S):S139-S146. doi: 10.1016/j.arth.2021.10.009. Epub 2022 Mar 7. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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