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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

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01872494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • 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.
  • comprehensive evaluation [ Time Frame: 48 hours postoperation ]
    Investigators document the comprehensive evaluation of patients with pain control system,including the incidence of adverse reactions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Local Analgesia for Postoperative Analgesia in Posterior Thoracolumbar Operation
Official Title  ICMJE Pain Treatment in Posterior Thoracolumbar Operation a Randomized Study to Assess the Effect of Local Analgesia After Operation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Other: local
    This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.
  • Other: intravenous
    This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
  • Drug: 0.33% ropivacaine 250ml
  • Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
Study Arms  ICMJE
  • Experimental: Local
    This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.
    Interventions:
    • Other: local
    • 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.
    Interventions:
    • Other: intravenous
    • Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2014)
71
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2013)
60
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01872494
Other Study ID Numbers  ICMJE local anaesthetic
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party bo xu, Guangzhou General Hospital of Guangzhou Military Command
Study Sponsor  ICMJE Guangzhou General Hospital of Guangzhou Military Command
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Guangzhou General Hospital of Guangzhou Military Command
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP