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Completed

NCT Number: NCT01344213

Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine

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

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Supranee Niruthisard

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pregabalin

Drug

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

Other names: Pregabalin: Lyrica

Celecoxib

Drug

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

Other names: Celecoxib: Celebrex

Pregabalin with celecoxib

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.

Other names: Pregabalin: Lyrica, Celecoxib: Celebrex

Placebo

Drug

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

Other names: Placebo: sugar capsule

Primary outcomes

  1. 24-hour cumulative morphine consumption

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • 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 outcomes

  1. Anxiety scores (VAS), patients' satisfaction

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • 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)

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Bhumibol Adulyadej Hospital
  • King Chulalongkorn Memorial Hospital

Registry information

Official study title

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

Acronym: PCTKA

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 29, 2011
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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