Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous Multimodal Analgesic Agent Injection Versus Periarticular Injection - A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- pain scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intraosseous multimodal analgesia injection
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
Intervention: Intraosseous Morphine (Procedure)
peri-articular multimodal analgesia 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.
Intervention: Periarticular Injection (Procedure)
Outcomes
Primary Outcomes
pain scores
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)
Secondary Outcomes
- Number of other Events of Morphine side effect(2 weeks after surgery)
- number of vomit events(at first 48 hours before discharge and after discharge for 2 weeks after surgery)
- ROM(before surgery and 24, 48hours and 2 weeks after surgery)
- Length of stays in hospital(up to 72 hours)
- Number of other complication(2 weeks)
- Morphine consumption(2 weeks)
- Timed up and go test(at 48 hours and 2 weeks after surgery)
- Time to walk(up to 48 hours)
- Operative time(up to 2 hours)
Investigators
Yot Tanariyakul
Comparative analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection - A Randomized Control Trial
Thammasat University Hospital