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The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA

A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01898052
Acronym
TKA
Enrollment
60
Registered
2013-07-12
Start date
2012-10-31
Completion date
2014-03-31
Last updated
2014-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

pain control, periarticular injection, Total knee arthroplasty, levobupivacaine, multimodal drug injection

Brief summary

The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.

Detailed description

Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy. In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.

Interventions

DRUGsingle anaesthetic drug

inject periarticular tissue of the knee after implantation

DRUGmultimodal drug injection

inject periarticular tissue of the knee

Sponsors

Thammasat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty * age 50-85 years old

Exclusion criteria

* unable to perform spinal anaesthesia * history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine * cognitive function impairment * renal impairment (creatinine clearance \< 30 mL/min) * liver impairment, gastrointestinal bleeding

Design outcomes

Primary

MeasureTime frameDescription
pain score48 hour after surgerypain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery

Secondary

MeasureTime frameDescription
time to request analgesic drug48 hourstime when patient request morphine from patient controlled analgesia after intra-operative drug injection

Other

MeasureTime frameDescription
drug consumption48 hoursmorphine consumption that record from patient controlled analgesia
knee score3 monthsKnee injury and osteoarthritis outcome score (KOOS) at pre-operation and post-operation 3 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026