Preemptive Analgesia in Total Knee Arthroplasty

Acute Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523832
• Other study ID #: 04
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2018
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Celecoxib and Pregabaline
Single dose versus repetition dose

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Morphine Consumption	In this study, morphine is given by patient control analgesia (PCA).	Third day post-operative
Secondary	Post-operative Pain	Measured 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.	every morning [daily], up to 3 days
Secondary	Knee functional outcome	Measured 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.	every morning [daily], up to 3 days
Secondary	Mobilization	The patient is expected to be able to do sitting motion	on the first day, standing on the second day, and walking on the third day