Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine

NCT01344213 | Completed Phase 4 DMC

• 1 other identifier: anesTKA08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty.

Conditions

Postoperative Pain Management; Total Knee Arthroplasty

Keywords

Pregabalin; Celecoxib; Intrathecal morphine; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 24-hour cumulative morphine consumption

  * The time to first morphine requirement will be recorded * The cumulative morphine consumption will be recorded at the end of surgery and 2-h, 6-h, 10-h, 24-h, and 48-h postoperatively * Visual analog scale (VAS) pain scores at rest will be assessed at the night before surgical date, before starting anesthesia, at the end of surgery, and 2-h, 6-h, 10-h, 24-h and 48-h postoperatively * Visual analog scale (VAS) pain scores when on movement will be assessed at the end of surgery, and 2-h, 6-h, 10-h, 24-h and 48-h postoperatively

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (1)

• Anxiety scores (VAS), patients' satisfaction

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (4)

Pregabalin

ACTIVE COMPARATOR

Oral single-dose of pregabalin (150 mg) and 1 capsule of placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.

Drug: Pregabalin

Celecoxib

ACTIVE COMPARATOR

Oral single-dose of celecoxib (400 mg) and 1 capsule of placebo (C) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.

Drug: Celecoxib

Pregabalin with celecoxib

ACTIVE COMPARATOR

Oral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.

Drug: Pregabalin with celecoxib

Placebo

PLACEBO COMPARATOR

Oral single-dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg

Drug: Placebo

Interventions

Pregabalin DRUG

Oral single-dose of pregabalin (150 mg) and placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.

Also known as: Pregabalin: Lyrica

Pregabalin

Celecoxib DRUG

Oral single-dose of celecoxib (400 mg) and placebo(C)1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.

Also known as: Celecoxib: Celebrex

Celecoxib

Pregabalin with celecoxib DRUG

Oral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.

Also known as: Pregabalin: Lyrica, Celecoxib: Celebrex

Pregabalin with celecoxib

Placebo DRUG

Oral single dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg

Also known as: Placebo: sugar capsule

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 50-75 years of age
• Patients with an American Society of Anesthesiologists physical status of I to III
• Patients scheduled for primary TKA with a diagnosis of osteoarthritis under spinal anesthesia

You may not qualify if:

• Patients had a known allergy to any of the medications being used
• a history of drug or alcohol abuse
• a history of taking chronic pain medications (ie, show-release preparations of opioids, given that morphine consumption was the primary outcome)
• a history of taking pregabalin or gabapentin / non-steroidal anti-inflammatory drugs / COX-2 inhibitors
• a psychiatric disorder
• a history of impaired renal function (Cr \> 1.5 mg/dl), peptic ulcer, asthma, thrombotic cerebrocardiovascular diseases, uncontrolled hypertension
• a history of contraindication for spinal anesthesia
• a history of bleeding tendency
• pregnancy
• unable or unwilling to use patient - controlled analgesic (PCA)

Sponsors & Collaborators

• Chulalongkorn University: lead
• Bhumibol Adulyadej Hospital: collaborator
• King Chulalongkorn Memorial Hospital: collaborator

Study Sites (1)

Supranee Niruthisard

Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

Pregabalin; Celecoxib

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Supranee Niruthisard, BSc, MD

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 29, 2011
• Study Start: July 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2010
• Last Updated: August 4, 2011

Record last verified: 2011-04

Locations

TH (1)