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

NCT06800846 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: TUH Intraosseous injection TKA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Postoperative; Total Knee Anthroplasty; Functional Outcomes

Keywords

peri-articular injection; intraosseous injection; multimodal analgesia cocktail; TKA; pain postoperative; functional outcomes

Outcome Measures

Primary Outcomes (1)

• pain scores

  Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)

  at 4, 6 hours and every 6 hours after surgery for 2 days, then daily for 2 weeks after surgery.

Secondary Outcomes (9)

• Morphine consumption

  2 weeks

• number of vomit events

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

• Number of other Events of Morphine side effect

  2 weeks after surgery

• ROM

  before surgery and 24, 48hours and 2 weeks after surgery

• Timed up and go test

  at 48 hours and 2 weeks after surgery

Study Arms (2)

Intraosseous multimodal analgesia injection

EXPERIMENTAL

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

Procedure: Intraosseous Morphine

peri-articular multimodal analgesia injection

ACTIVE COMPARATOR

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.

Procedure: Periarticular Injection

Interventions

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

Also known as: intraosseous injection

Intraosseous multimodal analgesia 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.

Also known as: peri-articular injection

peri-articular multimodal analgesia injection

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs of age ASA classification: 1-3 Unilateral TKA

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (3)

• 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.

  PMID: 37399631 BACKGROUND

• 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.

  PMID: 23850410 BACKGROUND

• 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.

  PMID: 35272897 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comparative analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection - A Randomized Control Trial

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 30, 2025
• Study Start: September 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)