Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine (PCTKA)

This study has been completed.
Sponsor:
Collaborators:
Bhumibol Adulyadej Hospital
King Chulalongkorn Memorial Hospital
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01344213
First received: April 26, 2011
Last updated: August 2, 2011
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:
  • Pregabalin: Lyrica
  • Celecoxib: Celebrex
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
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344213

Locations
Thailand
Supranee Niruthisard
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Bhumibol Adulyadej Hospital
King Chulalongkorn Memorial Hospital
Investigators
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 April 15, 2014