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Comparison of Two Kinds of Postoperative Analgesia After Amputation

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ClinicalTrials.gov Identifier: NCT02114463
Recruitment Status : Unknown
Verified March 2015 by bo xu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : April 15, 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:
Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.

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

Detailed Description:
Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial
Study Start Date : March 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 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: 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: flurbiprofen
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. Phantom pain [ Time Frame: three months postoperation ]
    Investigators asked the patient wether there is phantom pain at three months after surgery

  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 65 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 or 2
  2. Aged between 18 and 65 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): NCT02114463


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: Dong Xu Zhou    13268260337 ext 86    13268260337@163.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
More Information
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Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02114463    
Other Study ID Numbers: Phantom limb pain
First Posted: April 15, 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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Flurbiprofen
Analgesics
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action