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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272660
• Other study ID #: S-503
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2014
• Last updated: August 27, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Testing of body temperature,routine blood examination, IL-6 and IL-10		hospital admission and 1, 3, 6 days after the surgery	Yes
Primary	To evaluate the Morphine consumption in each group patients		4 hours to 6 days after the surgery	No
Secondary	To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration		4 hours to 6 days after the surgery	No
Secondary	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	No
Secondary	Function recovery of knee Range of Motion (ROM) for patients received surgery		3 and 6 days after the surgery	No