Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty :a Randomized Clinical Trial

Conditions
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Pain, Complications

Intervention / Treatment
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* Procedure: Local analgesic
* Procedure: Nerve Block
* Procedure: Intravenous analgesic
* Drug: ropivacaine
* Drug: ropivacaine
* Drug: opioid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local analgesic<br>This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia. | Procedure: Local analgesic<br>* 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.<br>Drug: ropivacaine<br>* 0.2% ropivacaine<br>|
| Active Comparator: Nerve Block<br>People in this group will receive a postoperative pain management by continuous lumbar plexus block with 0.2% ropivacaine. | Procedure: Nerve Block<br>* 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.<br>Drug: ropivacaine<br>* 0.2% ropivacaine<br>|
| Active Comparator: Intravenous analgesic<br>This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg. | Procedure: Intravenous analgesic<br>* 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.<br>Drug: opioid<br>* flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | 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 | 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 | Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al. | 72 hours postoperation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local analgesia system, Ropivacaine, Analgesic efficacy after operation, Postoperative