Preemptive Analgesia in Total Knee Arthroplasty

NCT03523832 | Completed Phase 2

• 1 other identifier: 04
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Total Morphine Consumption

  In this study, morphine is given by patient control analgesia (PCA).

  Third day post-operative

Secondary Outcomes (3)

• Post-operative Pain

  every morning [daily], up to 3 days

• Knee functional outcome

  every morning [daily], up to 3 days

• Mobilization

  on the first day, standing on the second day, and walking on the third day

Study Arms (3)

Group 1

ACTIVE COMPARATOR

celecoxib 400mg and pregabaline 150mg 1 hour before operation

Drug: Celecoxib and Pregabaline

Group 2

ACTIVE COMPARATOR

celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation

Drug: Celecoxib and Pregabaline

Group 3

PLACEBO COMPARATOR

No treatment given

Other: Placebo

Interventions

Celecoxib and Pregabaline DRUG

Single dose versus repetition dose

Group 1; Group 2

Placebo OTHER

Placebo

Group 3

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Related Publications (1)

• Lubis AMT, Rawung RBV, Tantri AR. Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial. Pain Res Treat. 2018 Aug 7;2018:3807217. doi: 10.1155/2018/3807217. eCollection 2018.

  PMID: 30174951 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 14, 2018
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2016
• Last Updated: August 6, 2019

Record last verified: 2018-04