- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02094339
Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty
March 11, 2015 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command
Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty :a Randomized Clinical Trial
Postoperative pain after total knee arthroplasty (TKA) can be difficult to manage and may delay recovery.
There are multimodal postoperative pain management after TKA, including intravenous opioids, epidural analgesia, peripheral nerve blocks or periarticular infiltration with local anesthetics.
All of these treatments may lead to side effects such as nausea, headache, hypotension, urinary retention, partial motor block and infection of the knee.
Therefore the investigators will compare three methods of postoperative analgesic after TKA by their efficiency and complication.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: bo xu, associate chief physician
- Phone Number: 020 88653387
- Email: xubo333@hotmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510010
- Recruiting
- Guangzhou Military Region General Hospital, Department of Anesthesiology
-
Contact:
- Tao Zhi Li
- Phone Number: 86 15625052815
- Email: lytow@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients of American Association of anesthetists(ASA)Grade 1、2 or 3
- Aged between 18 and 85 years
- Undergoing elective total knee replacement
Exclusion Criteria:
- Mental illness can not match
- Nerve block, epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- History of chronic headaches and long-term use of analgesic drugs
- People who were postoperative consciousness, language or hearing impaired
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Local analgesic
This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.
|
Patient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours.
0.2% ropivacaine
|
Active Comparator: Nerve Block
People in this group will receive a postoperative pain management by continuous lumbar plexus block with 0.2% ropivacaine.
|
0.2% ropivacaine
Combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine will be performed before the surgery.After the a bolus of 30mL ropivacaine around lumbar plexus,a catheter will be left in Psoas gap with 6cm.A pump elastomeric infusion pump running 5mL every hours will also be connected with the catheters at the end of the operation.
|
Active Comparator: Intravenous analgesic
This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine
30mg.
|
People in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine
30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery.
flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine
30mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: 72 hours postoperation
|
Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.
|
72 hours postoperation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sedation
Time Frame: 72 hours postoperation
|
At 2, 4, 6, 12, 24, 36, 48,72 hours after operation,sedation OAA/S scores are used to evaluate the level of sedation.
|
72 hours postoperation
|
complication
Time Frame: 72 hours postoperation
|
Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al.
|
72 hours postoperation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen EK, Soballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. doi: 10.1080/17453670710013645.
- Serpell MG, Millar FA, Thomson MF. Comparison of lumbar plexus block versus conventional opioid analgesia after total knee replacement. Anaesthesia. 1991 Apr;46(4):275-7. doi: 10.1111/j.1365-2044.1991.tb11495.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
March 19, 2014
First Submitted That Met QC Criteria
March 20, 2014
First Posted (Estimate)
March 21, 2014
Study Record Updates
Last Update Posted (Estimate)
March 12, 2015
Last Update Submitted That Met QC Criteria
March 11, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Unilateral Knee Replacement
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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