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Preemptive Analgesia in Total Knee Arthroplasty

Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combined Celecoxib With Pregabaline and Repetition Dose Combined Celecoxib With Pregabaline (Double Blind Controlled Clinical Trial)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03523832
Enrollment
30
Registered
2018-05-14
Start date
2015-07-01
Completion date
2016-12-31
Last updated
2019-08-06

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

Conditions

Acute Pain

Brief summary

Acute Pain is the most common early complication after total knee arthroplasty that caused delayed mobilization, demands of morphine, and higher operative cost. There were many researches that had been done in analgesia method to find the most effective analgesia, lowest side effect, and easy to apply. Preemptive analgesia of combined celecoxib and pregabalin were reported to give a promising outcome. In a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. First group was given celecoxib 400mg and pregabaline 150mg 1 hour before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation, and the last group was given placebo. The outcome was measured with VAS, knee ROM, and post-operative mobilization

Interventions

DRUGCelecoxib and Pregabaline

Single dose versus repetition dose

OTHERPlacebo

Placebo

Sponsors

Fakultas Kedokteran Universitas Indonesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 55-80 years old patients who come to orthopaedic polyclinic * underwent TKA procedure * have osteoarthritis * consumed pain killer and anti inflamatory drugs routinely

Exclusion criteria

* psychiatric disorder * have history of renal disease * histroy of chronic neurophatic * have genu arthritis that caused by rheumatid arthritis and infection * diabetic and obesity * coagulopathy * patients with severe pain that needed immediate analgesia regimen

Design outcomes

Primary

MeasureTime frameDescription
Total Morphine ConsumptionThird day post-operativeIn this study, morphine is given by patient control analgesia (PCA).

Secondary

MeasureTime frameDescription
Post-operative Painevery morning [daily], up to 3 daysMeasured and evaluated by Visual Analogue Scale (VAS). VAS score of 1-10. With the maximal of 10. Ranging from no pain to unbearable pain. Worst pain is in score 10.
Knee functional outcomeevery morning [daily], up to 3 daysMeasured by active knee range of motion using goniometer. The outcome scale is in degree range of motion. The knee range of motion is 0 degree (total extension) to 135 degree (full flexion). The more range of motion degree, the better the result.
Mobilizationon the first day, standing on the second day, and walking on the third dayThe patient is expected to be able to do sitting motion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026