Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine (PCTKA)
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Purpose
To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain Management Total Knee Arthroplasty |
Drug: Pregabalin Drug: Celecoxib Drug: Pregabalin with celecoxib Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Analgesic Efficacy Among Pregabalin, Celecoxib, Pregabalin With Celecoxib and Placebo After Total Knee Arthroplasty Under Intrathecal Morphine |
- 24-hour cumulative morphine consumption [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
- 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
- Anxiety scores (VAS), patients' satisfaction [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
- 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)
| Enrollment: | 100 |
| Study Start Date: | July 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pregabalin
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
Oral single-dose of pregabalin (150 mg) and placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
Other Name: Pregabalin: Lyrica
|
|
Active Comparator: Celecoxib
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
Oral single-dose of celecoxib (400 mg) and placebo(C)1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
Other Name: Celecoxib: Celebrex
|
|
Active Comparator: Pregabalin with celecoxib
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
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.
Other Names:
|
|
Placebo Comparator: Placebo
Oral single-dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg
|
Drug: Placebo
Oral single dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg
Other Name: Placebo: sugar capsule
|
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| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Thailand | |
| Supranee Niruthisard | |
| Bangkok, Thailand, 10330 | |
| Principal Investigator: | Supranee Niruthisard, BSc, MD | King Chulalongkorn Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Assoc.Professor Supranee Niruthisard, Department of Anesthesiology, Faculty of Medicine, Chulalongkorn Unv. |
| ClinicalTrials.gov Identifier: | NCT01344213 History of Changes |
| Other Study ID Numbers: | anesTKA08 |
| Study First Received: | April 26, 2011 |
| Last Updated: | August 2, 2011 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Chulalongkorn University:
|
Pregabalin Celecoxib Intrathecal morphine Total knee arthroplasty |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Morphine Pregabalin Celecoxib Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics Anticonvulsants Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013