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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01344213
Other study ID # anesTKA08
Secondary ID
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


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
See also
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