Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000463572
Ethics application status
Approved
Date submitted
26/02/2015
Date registered
12/05/2015
Date last updated
12/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management of Postoperative Pain After Total Knee Arthroplasty
Scientific title
Analgesic Effects of Intraarticular Bupivacaine in Patients Receiving Total Knee Arthroplasty
Secondary ID [1] 286280 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain 294349 0
Condition category
Condition code
Anaesthesiology 294669 294669 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Analgesic effects of intravenous parecoxib have been investigated in orthopedic surgery. Postoperative pain is still a common problem after total knee arthroplasty. The purpose of this double-blind, randomized study was to investigate whether the addition of intraarticular bupivacaine to intravenous parecoxib could improve pain relief in patients receiving total knee arthroplasty. One hour before operation, a single dose of parecoxib 40 mg was injected intravenously within 30 seconds. After the closure of the surgical wound, a single dose of intraarticular injection of 0.5% bupivacaine 60 ml (300 mg) was given into the joint space within 2 minutes.
Intervention code [1] 291305 0
Treatment: Drugs
Comparator / control treatment
In the control group, patients received the intravenous parecoxib 40 mg injection as per the intervention group, but received a placebo (intraarticular 0.9% normal saline 60 ml) instead of the intraarticular 0.5% bupivacaine.
Control group
Placebo

Outcomes
Primary outcome [1] 294422 0
Pain numeric rating scale score
Timepoint [1] 294422 0
immediately post operation
Secondary outcome [1] 313276 0
The secondary outcome was the amount of meperidine use within the first 24 hours after the operation.
After operation, the Numeric Rating Scale (NRS) scores, wherein score 0 denoted no pain and score 10 denoted the worst pain, were used for the first time for pain assessment. If the NRS score exceeded 4, an intramuscular meperidine 50 mg injection was given for pain relief. The frequency of assessment was every 4 hours and an intramuscular meperidine 50-mg injection was given if needed.
Timepoint [1] 313276 0
the first 24 hours after operation

Eligibility
Key inclusion criteria
patient with knee osteoarthritis who was indicated for total knee arthroplasty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
neuropathic pain or sensory disorder in the knee required surgery, coagulation abnormalities, severe renal or hepatic impairment, and chronic opioid use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2012
Actual
10/12/2012
Date of last participant enrolment
Anticipated
Actual
25/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 6704 0
Taiwan, Province Of China
State/province [1] 6704 0

Funding & Sponsors
Funding source category [1] 290836 0
Self funded/Unfunded
Name [1] 290836 0
Country [1] 290836 0
Primary sponsor type
Individual
Name
Huang-Ping Yu
Address
5 Fu-shin street, Kweishan, Taoyuan 333
Chang Gung Memorial Hospital
Country
Taiwan, Province Of China
Secondary sponsor category [1] 289527 0
None
Name [1] 289527 0
Address [1] 289527 0
Country [1] 289527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292458 0
Chang Gung Medical Foundation
Ethics committee address [1] 292458 0
Ethics committee country [1] 292458 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 292458 0
Approval date [1] 292458 0
09/11/2012
Ethics approval number [1] 292458 0
101-3444B

Summary
Brief summary
Analgesic effects of intravenous parecoxib have been investigated in orthopedic surgery. Postoperative pain is still a common problem after total knee arthroplasty. Recent studies have shown that intraarticular bupivacaine injection has analgesic effect after total hip replacement and good opioid-sparing effect at the first 12 hours after hip surgery. Local anesthetic is injected into intraarticular cavity after surgical wound closure, spreading into muscle and soft tissue, which can effectively decrease postoperative pain. In view of this, we hypothesized that intraarticular bupivacaine in combination with intravenous parecoxib might improve postoperative pain relief in patients receiving total knee arthroplasty.
Trial website
Trial related presentations / publications
There are no related trial presentations/publications now.
Public notes

Contacts
Principal investigator
Name 55390 0
Dr Huang-Ping Yu
Address 55390 0
5 Fu-shin street, Kwei-shan, Taoyuan 333
Chang Gung Memorial Hospital
Country 55390 0
Taiwan, Province Of China
Phone 55390 0
+88633281200ext2324
Fax 55390 0
Email 55390 0
yuhp2001@adm.cgmh.org.tw
Contact person for public queries
Name 55391 0
Dr Huang-Ping Yu
Address 55391 0
5 Fu-shin street, Kwei-shan, Taoyuan 333
Chang Gung Memorial Hospital
Country 55391 0
Taiwan, Province Of China
Phone 55391 0
+88633281200ext2324
Fax 55391 0
Email 55391 0
yuhp2001@adm.cgmh.org.tw
Contact person for scientific queries
Name 55392 0
Dr Huang-Ping Yu
Address 55392 0
5 Fu-shin street, Kwei-shan, Taoyuan 333
Chang Gung Memorial Hospital
Country 55392 0
Taiwan, Province Of China
Phone 55392 0
+88633281200ext2324
Fax 55392 0
Email 55392 0
yuhp2001@adm.cgmh.org.tw

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAnalgesic effects of intra-articular bupivacaine/intravenous parecoxib combination therapy versus intravenous parecoxib monotherapy in patients receiving total knee arthroplasty: A randomized, double-blind trial.2015https://dx.doi.org/10.1155/2015/450805
N.B. These documents automatically identified may not have been verified by the study sponsor.