Efficacy and Safety of Postoperative Intravenous Parecoxib Sodium Followed by Oral Celecoxib in Osteoarthritis Patients
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
In mainland China, knee Osteoarthritis (OA) is the leading cause of disability in older
persons. Total knee arthroplasty (TKA) is now generally regarded by orthopaedic surgeons and
patients as an effective treatment for end-stage knee OA in order to relieve pain, correct
joint deformity and improve the life quality of patients.However, TKA has been called as one
of the most painful Orthopedics surgery due to the weight bearing characteristics of knee
joint and the high demand of functional exercise within the 6-8 weeks post operation. The
targeted application of selective cyclooxygenase (COX) -2 inhibitor, such as Parecoxib or
Celecoxib, can significantly reduce the level of inflammatory reaction one and two days
postoperation . In addition, the perioperative administration of Celecoxib can directly or
indirectly relieve postoperative pain, improve articular function and eventually augment life
quality of the patients . Recently, effective treatment of post-operative pain with
intravenous followed by oral COX-2 specific inhibitor has been demonstrated in many
post-operative pain models . Significant morphine sparing effect and reduction of opioid
distressed symptoms were also observed. In China, many surgeons have accept it as a routine
strategy for controlling pain post TKA to sequentially give parecoxib 40 mg intravenously
twice daily for the first 3 days post surgery and then Celecoxib 200mg orally twice daily.
Although satisfactory results of this combination treatment on short-term pain reduction and
functional improvement has been observed in clinical practice, high quality evidence is still
lacking to prove its effect on the medium or long-term functionality recovery. This study is
being conducted to investigate the combination regimen with intravenous parecoxib followed by
oral celecoxib for post-surgical analgesic treatment in osteoarthritis patients undergoing
total knee arthroplastic (TKA) surgery. Subjects will receive double-blinded study medication
consisting of parecoxib injection in analgesic doses or matching placebo followed by oral
celecoxib in acute pain doses or matching placebo in a double-blinded fashion. The hypothesis
is subjects treated with parecoxib/celecoxib will consume less morphine over the first 24
hours of postoperation period, achieve improved pain control over study period, a quicker
return to functionality, and has less opioid adverse events than those treated with opioids
alone over 6-week recovery phase.