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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Parecoxib sodium; Drug: Normal saline injection

• Registration Number: NCT02272660
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parecoxib sodium	Parecoxib sodium	The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision.
Normal saline injection	Normal saline injection	The control group received 2 mL normal saline injection at the same time point.

Primary Outcome Measures

Name	Time	Method
To evaluate the Morphine consumption in each group patients	4 hours to 6 days after the surgery

Secondary Outcome Measures

Name	Time	Method
To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration	4 hours to 6 days after the surgery
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
Function recovery of knee Range of Motion (ROM) for patients received surgery	3 and 6 days after the surgery

Trial Locations

Locations (1)

The Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China