Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine

Total Knee Arthroplasty Clinical Trial

— PCTKA  

Official title:

Comparison of Analgesic Efficacy Among Pregabalin, Celecoxib, Pregabalin With Celecoxib and Placebo After Total Knee Arthroplasty Under Intrathecal Morphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344213
• Other study ID #: anesTKA08
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2011
• Last updated: August 2, 2011
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: April 2011
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Management
• Total Knee Arthroplasty

Intervention

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

Locations

Country	Name	City	State
Thailand	Supranee Niruthisard	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Chulalongkorn University	Bhumibol Adulyadej Hospital, King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour cumulative morphine consumption	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	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Yes
Secondary	Anxiety scores (VAS), patients' satisfaction	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)	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Yes