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Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02094339
Recruitment Status : Unknown
Verified March 2015 by bo xu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : March 21, 2014
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
bo xu, Guangzhou General Hospital of Guangzhou Military Command

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Complications Procedure: Local analgesic Procedure: Nerve Block Procedure: Intravenous analgesic Drug: ropivacaine Drug: opioid Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty :a Randomized Clinical Trial
Study Start Date : March 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Local analgesic
This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.
 Procedure: Local analgesic
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.

Drug: ropivacaine
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.
 Procedure: Nerve Block
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.

Drug: ropivacaine
0.2% ropivacaine
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.
 Procedure: Intravenous analgesic
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.

Drug: opioid
flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. complication [ Time Frame: 72 hours postoperation ]
    Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
  2. Aged between 18 and 85 years
  3. Undergoing elective total knee replacement

Exclusion Criteria:

  1. Mental illness can not match
  2. Nerve block, epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. History of chronic headaches and long-term use of analgesic drugs
  5. People who were postoperative consciousness, language or hearing impaired
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094339


Contacts
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Contact: bo xu, associate chief physician 88653387 ext 020 xubo333@hotmail.com

Locations
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China, Guangdong
Guangzhou Military Region General Hospital, Department of Anesthesiology Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Tao Zhi Li    15625052815 ext 86    lytow@qq.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
More Information
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Publications of Results:

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Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02094339    
Other Study ID Numbers: Unilateral Knee Replacement
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015
Keywords provided by bo xu, Guangzhou General Hospital of Guangzhou Military Command:
Local analgesia system
Ropivacaine
Analgesic efficacy after operation
Postoperative
Additional relevant MeSH terms:
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Analgesics
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents