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)

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

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Other: Placebo; Drug: Celecoxib and Pregabaline

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; celecoxib 400mg and pregabaline 150mg 1 hour before operation	Drug: Celecoxib and Pregabaline; Single dose versus repetition dose
Active Comparator: Group 2; celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation	Drug: Celecoxib and Pregabaline; Single dose versus repetition dose
Placebo Comparator: Group 3; No treatment given	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Morphine Consumption	In this study, morphine is given by patient control analgesia (PCA).	Third day post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Cyclooxygenase 2 Inhibitors; Calcium Channel Blockers; Celecoxib; Pregabalin
• Other Study ID Numbers: 04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No