The Impact of Local Analgesia for Postoperative Analgesia in Posterior Thoracolumbar Operation

Study Overview
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Brief Summary
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Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma and rich periosteum and joint capsule innervation, patients after general anesthesia immediately feel acute pain.The use of appropriate postoperative analgesia in patients with thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic via multilumen catheters that deliver directly to wound sites have been used for postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will make the mode of analgesia a better tolerated and more palatable option for patients. The aim of this study is to examine the effects of using local anaesthetic infusion catheters following posterior thoracolumbar surgery, and compares the outcomes of patients managed using intravenous analgesia pump infusion of systemic opioids.

Detailed Description
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All 71 adult patients were prospectively included and randomized to either the local (L) group (n=35) or the intravenous (V) group (n=36) by using a random number table: the test group were treated with local analgesia infusion pump of 0.33% ropivacaine through the wound for postoperative analgesia, while the control group were treated with intravenous analgesia pump infusion of flurbiprofen axetil,palonosetron, pentazocine. At 2, 4, 6, 12, 24, 36, 48 hours after operation, postoperative pain visual analogue scale(VAS) scores and sedation Ramsay scores were used to evaluate the level of pain and sedation, and investigators documented the comprehensive evaluation of patients with pain control system, and the incidence of adverse reactions. At 24, 48 hours investigators observed the wound whether inflammation and exudation or not, and the removal of penetration catheter sent to clinical laboratory for bacterial culture. Investigators also recorded the length of time to discharge and called to ask pain conditions at the first 3 months.

Official Title
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Pain Treatment in Posterior Thoracolumbar Operation a Randomized Study to Assess the Effect of Local Analgesia After Operation

Conditions
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Pain

Intervention / Treatment
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* Other: local
* Other: intravenous
* Drug: 0.33% ropivacaine 250ml
* Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA Ⅰ   Ⅱ patient undergoing elective posterior thoracolumbar operation between 18 and 70 years of age Exclusion Criteria: A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation Preoperative use of analgesic drugs A allergy history of ropivacaine and polyurethane material

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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<br>This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia. | Other: local<br>* This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.<br>Drug: 0.33% ropivacaine 250ml<br> <br> |
| Active Comparator: intravenous<br>This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg. | Other: intravenous<br>* This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.<br>Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Up to 48 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain. | 48 hours postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation | At 2, 4, 6, 12, 24, 36, 48 hours after operation,sedation Ramsay scores are used to evaluate the level of sedation. | 48 hours postoperation | 
| comprehensive evaluation | Investigators document the comprehensive evaluation of patients with pain control system,including the incidence of adverse reactions. | 48 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