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Completed

NCT Number: NCT02272660

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

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Parecoxib Sodium

Drug

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

Normal saline injection

Drug

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

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2014
Registry last updated
Aug 28, 2015

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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