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

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ClinicalTrials.gov Identifier: NCT01872494
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
bo xu, Guangzhou General Hospital of Guangzhou Military Command

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Other: local Other: intravenous Drug: 0.33% ropivacaine 250ml Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg. Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Treatment in Posterior Thoracolumbar Operation a Randomized Study to Assess the Effect of Local Analgesia After Operation
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Local
This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.
Other: local
This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.

Drug: 0.33% ropivacaine 250ml
Active Comparator: intravenous
This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
Other: intravenous
This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.

Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.



Primary Outcome Measures :
  1. pain [ Time Frame: 48 hours postoperation ]
    Up to 48 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: 48 hours postoperation ]
    At 2, 4, 6, 12, 24, 36, 48 hours after operation,sedation Ramsay scores are used to evaluate the level of sedation.

  2. comprehensive evaluation [ Time Frame: 48 hours postoperation ]
    Investigators document the comprehensive evaluation of patients with pain control system,including the incidence of adverse reactions.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ASA Ⅰ ~ Ⅱ patient undergoing elective posterior thoracolumbar operation
  2. between 18 and 70 years of age

Exclusion Criteria:

  1. A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation
  2. Preoperative use of analgesic drugs
  3. A allergy history of ropivacaine and polyurethane material

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): NCT01872494


Locations
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China, Guangdong
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, China, 510010
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command

Publications:
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Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01872494     History of Changes
Other Study ID Numbers: local anaesthetic
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: May 2014

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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Ropivacaine
Pentazocine
Palonosetron
Flurbiprofen
Flurbiprofen axetil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Narcotic Antagonists