NCT02272660

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

October 17, 2014

Last Update Submit

August 27, 2015

Conditions

Pain, Postoperative

Keywords

preemptive analgesiaparecoxib sodiumtotal knee arthroplastytotal hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • To evaluate the Morphine consumption in each group patients

    4 hours to 6 days after the surgery

Secondary Outcomes (3)

  • 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 Outcomes (1)

  • Testing of body temperature,routine blood examination, IL-6 and IL-10

    hospital admission and 1, 3, 6 days after the surgery

Study Arms (2)

Parecoxib sodium

EXPERIMENTAL

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

Drug: Parecoxib sodium

Normal saline injection

PLACEBO COMPARATOR

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

Drug: Normal saline injection

Interventions

Parecoxib sodiumDRUG

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
Parecoxib sodium
Normal saline injectionDRUG

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
Normal saline injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxibSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Zhihong Wu, Prof

    PUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 23, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

CN(1)