Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraosseous Morphine, Periarticular Injection.
- Who it may be relevant to
- Registry conditions: Pain Postoperative, Total Knee Anthroplasty, Functional Outcomes. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous Multimodal Analgesic Agent Injection Versus Periarticular Injection - A Randomized Control Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- pain scores [Time frame: at 4, 6 hours and every 6 hours after surgery for 2 days, then daily for 2 weeks after surgery.]
Secondary outcome measures (9)
- Morphine consumption [Time frame: 2 weeks]
- 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 [Time frame: 2 weeks after surgery]
- ROM [Time frame: before surgery and 24, 48hours and 2 weeks after surgery]
- Timed up and go test [Time frame: at 48 hours and 2 weeks after surgery]
- Length of stays in hospital [Time frame: up to 72 hours]
- Time to walk [Time frame: up to 48 hours]
- Operative time [Time frame: up to 2 hours]
- Number of other complication [Time frame: 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Thammasat University Hospital — Khlong Luang
Publications
- 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. PMID 37399631
- 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. PMID 23850410
- 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. PMID 35272897
Identifiers
NCT: NCT06800846 · TUH Intraosseous injection TKA