Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection

Thammasat University Hospital

Status and phase: Invitation-only; Phase 4

Conditions: Functional Outcomes; Total Knee Anthroplasty; Pain Postoperative

Treatments: Procedure: Periarticular Injection; Procedure: Intraosseous Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06800846

TUH Intraosseous injection TKA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Intraosseous multimodal analgesia injection

Experimental group

Description:

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

Treatment:

Procedure: Intraosseous Morphine

peri-articular multimodal analgesia injection

Active Comparator group

Description:

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.

Treatment:

Procedure: Periarticular Injection