Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine

NCT ID: NCT01344213

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-10-31

Brief Summary

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

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.

Conditions

Postoperative Pain Management; Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin with celecoxib

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Pregabalin

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Pregabalin: Lyrica; Celecoxib: Celebrex; Pregabalin: Lyrica; Celecoxib: Celebrex; Placebo: sugar capsule

Eligibility 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bhumibol Adulyadej Hospital

OTHER

Sponsor Role: collaborator

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn Unv.

Principal Investigators

Supranee Niruthisard, BSc, MD

Role: PRINCIPAL_INVESTIGATOR

King Chulalongkorn Memorial Hospital

Locations

Supranee Niruthisard

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

anesTKA08

Identifier Type: -

Identifier Source: org_study_id