Clinical trial NCT06800846: Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection
Official title: Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous Multimodal Analgesic Agent Injection Versus Periarticular Injection - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Pain Postoperative
Total Knee Anthroplasty
Functional Outcomes
Keywords: peri-articular injection
intraosseous injection
multimodal analgesia cocktail
TKA
pain postoperative
functional outcomes
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain scores
timeFrame: at 4, 6 hours and every 6 hours after surgery for 2 days, then daily for 2 weeks after surgery.
Secondary outcomes:
measure: Morphine consumption
timeFrame: 2 weeks
measure: number of vomit events
timeFrame: at first 48 hours before discharge and after discharge for 2 weeks after surgery
measure: Number of other Events of Morphine side effect
timeFrame: 2 weeks after surgery
measure: ROM
timeFrame: before surgery and 24, 48hours and 2 weeks after surgery
measure: Timed up and go test
timeFrame: at 48 hours and 2 weeks after surgery
measure: Length of stays in hospital
timeFrame: up to 72 hours
measure: Time to walk
timeFrame: up to 48 hours
measure: Operative time
timeFrame: up to 2 hours
measure: Number of other complication
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University Hospital
state: Pathum Thani
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.