DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017