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Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02272660
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Zhihong Wu, Peking Union Medical College Hospital

Brief Summary:
Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Parecoxib sodium Drug: Normal saline injection Phase 4

Detailed Description:

Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management.

We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parecoxib sodium
The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision.
Drug: Parecoxib sodium
The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
Other Name: Dynastat

Placebo Comparator: Normal saline injection
The control group received 2 mL normal saline injection at the same time point.
Drug: Normal saline injection
The patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
Other Name: Physiological saline




Primary Outcome Measures :
  1. To evaluate the Morphine consumption in each group patients [ Time Frame: 4 hours to 6 days after the surgery ]

Secondary Outcome Measures :
  1. To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration [ Time Frame: 4 hours to 6 days after the surgery ]
  2. To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty [ Time Frame: 4 hours to 6 days after the surgery ]
  3. Function recovery of knee Range of Motion (ROM) for patients received surgery [ Time Frame: 3 and 6 days after the surgery ]

Other Outcome Measures:
  1. Testing of body temperature,routine blood examination, IL-6 and IL-10 [ Time Frame: hospital admission and 1, 3, 6 days after the surgery ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).
  2. Age between 18-65 years.
  3. Chinese ethnicity.

Exclusion Criteria:

  1. patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.
  2. patient exhibited allergy to parecoxib sodium.
  3. lactating or pregnant.
  4. any other conditions not suitable for surgery as evaluated by the surgeon in charge.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272660


Locations
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China, Beijing
The Peking Union Medical College Hospital
Beijing, Beijing, China, 100005
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Zhihong Wu, Prof PUMC

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Responsible Party: Zhihong Wu, Prof, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02272660     History of Changes
Other Study ID Numbers: S-503
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Zhihong Wu, Peking Union Medical College Hospital:
preemptive analgesia
parecoxib sodium
total knee arthroplasty
total hip arthroplasty
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Parecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents