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Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by bo xu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02094339
First Posted: March 21, 2014
Last Update Posted: March 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
bo xu, Guangzhou General Hospital of Guangzhou Military Command
  Purpose
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 Intervention Phase
Pain Complications Procedure: Local analgesic Procedure: Nerve Block Procedure: Intravenous analgesic Drug: ropivacaine Drug: opioid Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by bo xu, Guangzhou General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • 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:
  • 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.

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


Estimated Enrollment: 45
Study Start Date: March 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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

Locations
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

Publications:
Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02094339     History of Changes
Other Study ID Numbers: Unilateral Knee Replacement
First Submitted: March 19, 2014
First Posted: March 21, 2014
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:
Ropivacaine
Pentazocine
Dezocine
Flurbiprofen
Flurbiprofen axetil
Analgesics
Palonosetron
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Narcotic Antagonists