Total Knee Arthroplasty Clinical Trial
— PCTKAOfficial title:
Comparison of Analgesic Efficacy Among Pregabalin, Celecoxib, Pregabalin With Celecoxib and Placebo After Total Knee Arthroplasty Under Intrathecal Morphine
Verified date | April 2011 |
Source | Chulalongkorn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2010 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria:. - 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Supranee Niruthisard | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University | Bhumibol Adulyadej Hospital, King Chulalongkorn Memorial Hospital |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Anxiety scores (VAS), patients' satisfaction | Anxiety scores 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; 24-h and 48-h patients' satisfaction (0-10,0=dissatisfied and 10= very satisfied) |
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Yes |
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