Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine
Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain Management; Total Knee Arthroplasty
Intervention: Pregabalin (Drug); Celecoxib (Drug); Pregabalin with celecoxib (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Chulalongkorn University Official(s) and/or principal investigator(s): Supranee Niruthisard, BSc, MD, Principal Investigator, Affiliation: King Chulalongkorn Memorial Hospital
Summary
To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of
intrathecal morphine for patients after total knee arthroplasty.
Clinical Details
Official title: Comparison of Analgesic Efficacy Among Pregabalin, Celecoxib, Pregabalin With Celecoxib and Placebo After Total Knee Arthroplasty Under Intrathecal Morphine
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 24-hour cumulative morphine consumption
Secondary outcome: Anxiety scores (VAS), patients' satisfaction
Detailed description:
A single-dose spinal anesthesia combining with morphine for total knee arthroplasty (TKA) is
a simple, economical anesthetic technique commonly used in our hospital. Still some
patients could not get effective postoperative pain control. Pregabalin, an anticonvulsant,
has been shown to reduce acute pain after molar extraction, laparoscopic cholecystectomy,
and reduce postoperative morphine requirement after total hip arthroplasty, and celecoxib, a
selective cyclo-oxygenase (COX) - 2 inhibitor, with perioperative prescription is
successfully reduces pain score and opioid consumption after TKA under spinal anesthesia
alone. However, no clinical study has yet investigated whether preoperative single-dose of
pregabalin, celecoxib or in combination compared to placebo can improve analgesic efficacy
of intrathecal morphine after TKA. The primary objective of this study was to evaluate
whether these medications could reduce pain scores at rest / when movement and morphine
requirement after TKA under spinal anesthesia with intrathecal morphine. Secondary outcome
assessed include adverse effects, anxiety score and patients' satisfaction score.
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Supranee Niruthisard, Bangkok 10330, Thailand
Additional Information
Starting date: July 2008
Last updated: August 2, 2011
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