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CompletedNCT02272660Updated Aug 28, 2015

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

A Phase 4 interventional study of Parecoxib sodium and Normal saline injection in Pain, Postoperative, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-28.

Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • preemptive analgesia
  • parecoxib sodium
  • total knee arthroplasty
  • total hip arthroplasty
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 74 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Parecoxib sodium

    The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision.

    Drug: Parecoxib sodium

  • Placebo comparator
    Normal saline injection

    The control group received 2 mL normal saline injection at the same time point.

    Drug: Normal saline injection

Interventions

  • DrugParecoxib 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.

    Also known as: Dynastat

  • DrugNormal 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.

    Also known as: Physiological saline

06

What researchers measure

Primary outcomes

  1. To evaluate the Morphine consumption in each group patients

    Time frame: 4 hours to 6 days after the surgery

Secondary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • The Peking Union Medical College Hospital
    Beijing, Beijing 100005, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02272660
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Zhihong Wu (Prof, Peking Union Medical College Hospital) — Principal investigator
First posted
Oct 23, 2014
Start date
Oct 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Aug 28, 2015

Study contacts

Zhihong Wu, Prof
principal investigator · PUMC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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