Comparison of Two Kinds of Postoperative Analgesia After Amputation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial

Conditions
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Pain, Complications

Intervention / Treatment
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* Procedure: Local analgesic
* Procedure: Intravenous analgesic
* Drug: ropivacaine
* Drug: flurbiprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of American Association of anesthetists（ASA）Grade 1 or 2 Aged between 18 and 65 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: 65 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: 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: flurbiprofen<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 |
| --- | --- | --- |
| Phantom pain | Investigators asked the patient wether there is phantom pain at three months after surgery | three months 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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Ropivacaine, Local analgesia system, Analgesic efficacy after operation, Postoperative