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

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Parecoxib sodium; Drug: Normal saline injection

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • The Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the Morphine consumption in each group patients	4 hours to 6 days after the surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Testing of body temperature,routine blood examination, IL-6 and IL-10	hospital admission and 1, 3, 6 days after the surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Zhihong Wu, Prof, PUMC

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Estimate): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: total hip arthroplasty; preemptive analgesia; total knee arthroplasty; parecoxib sodium
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: S-503