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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Postoperative Total Knee Anthroplasty Functional Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Intraosseous Morphine

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Periarticular Injection

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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intraosseous injection peri-articular injection

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yot Tanariyakul

Comparative analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection - A Randomized Control Trial

Responsibility Role PRINCIPAL_INVESTIGATOR