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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02272660
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
10
Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

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 Names:
  • 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 Names:
  • Physiological saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the Morphine consumption in each group patients [4 hours to 6 days after the surgery]

    Secondary Outcome Measures

    1. To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration [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 [4 hours to 6 days after the surgery]

    3. Function recovery of knee Range of Motion (ROM) for patients received surgery [3 and 6 days after the surgery]

    Other Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Peking Union Medical College Hospital Beijing Beijing China 100005

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Zhihong Wu, Prof, PUMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhihong Wu, Prof, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT02272660
    Other Study ID Numbers:
    • S-503
    First Posted:
    Oct 23, 2014
    Last Update Posted:
    Aug 28, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Zhihong Wu, Prof, Peking Union Medical College Hospital
    preemptive analgesia
    parecoxib sodium
    total knee arthroplasty
    total hip arthroplasty
    Additional relevant MeSH terms:
    Pain, Postoperative
    Parecoxib

    Study Results

    No Results Posted as of Aug 28, 2015