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NCT Number: NCT06800846

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

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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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraosseous Morphine

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

Other names: intraosseous injection

Periarticular Injection

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.

Other names: peri-articular injection

Primary outcomes

  1. 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

  1. Morphine consumption

    Time frame: 2 weeks

    Morphine consumption in hospital 48 hours before discharge and MST as home medication for 2 weeks (MME)

  2. number of vomit events

    Time frame: at first 48 hours before discharge and after discharge for 2 weeks after surgery

    number of vomit events

  3. Number of other Events of Morphine side effect

    Time frame: 2 weeks after surgery

    Itching, rash, constipation, difficult urination, respiratory, etc.

  4. ROM

    Time frame: before surgery and 24, 48hours and 2 weeks after surgery

    ROM (degree)

  5. Timed up and go test

    Time frame: at 48 hours and 2 weeks after surgery

    start with standing and then walk for 3 meters, then turn back to seat for 3 meters, then sit (report in seconds)

  6. Length of stays in hospital

    Time frame: up to 72 hours

    Number of hours the patient stays for surgery

  7. Time to walk

    Time frame: up to 48 hours

    hours after surgery of patients at first start walking to the toilet

  8. Operative time

    Time frame: up to 2 hours

    duration from start incision to wound closure in TKA procedure (minutes)

  9. Number of other complication

    Time frame: 2 weeks

    clinical VTE, wound and skin complication, superficial and deep infection

Sponsors and collaborators

Lead sponsor

Thammasat University Hospital

Other

Registry information

Official study title

Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous Multimodal Analgesic Agent Injection Versus Periarticular Injection - A Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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