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Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ehab Farag, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00840996
First received: February 10, 2009
Last updated: October 31, 2016
Last verified: October 2016
Results First Received: June 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Spine Surgery
Interventions: Drug: Lidocaine
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
With approval of the institutional review board at the Cleveland Clinic and written informed consent, between September 2009 to October 2011 we enrolled 116 patients to undergo elective multi-level spine surgery At Cleveland Clinic, Cleveland, Ohio, USA .

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lidocaine Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Placebo Perioperative equal volume of saline placebo IV infusion

Participant Flow:   Overall Study
    Lidocaine   Placebo
STARTED   58   58 
COMPLETED   57   58 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lidocaine Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Placebo Perioperative equal volume of saline placebo IV infusion
Total Total of all reporting groups

Baseline Measures
   Lidocaine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   58   115 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (11)   54  (11)   56  (11) 
Gender 
[Units: Participants]
Count of Participants
     
Female      22  38.6%      23  39.7%      45  39.1% 
Male      35  61.4%      35  60.3%      70  60.9% 


  Outcome Measures
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1.  Primary:   Mean Pain Scores   [ Time Frame: From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier). ]

2.  Primary:   Opioid Medication Requirement, mg in IV Morphine Equivalent   [ Time Frame: through postoperative day 2 (or discharge, if earlier) ]

3.  Secondary:   Number of Participants With Any Major 30-day Post Operative Complications   [ Time Frame: 30 days after surgery ]

4.  Secondary:   Postoperative Nausea and Vomiting (PONV)   [ Time Frame: post op day one and two or till hospital discharge ]

5.  Secondary:   Duration of Hospitalization   [ Time Frame: At discharge ]

6.  Secondary:   12-item Short Form Survey (SF-12) Physical Health Composite Score   [ Time Frame: 30 days post operative ]

7.  Secondary:   12-item Short Form Survey (SF-12) Physical Health Composite Score   [ Time Frame: 90 days post operative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Roberta Johnson
Organization: Cleveland Clinic
phone: 216-444-9950
e-mail: johnsor13@ccf.org



Responsible Party: Ehab Farag, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00840996     History of Changes
Obsolete Identifiers: NCT00706524
Other Study ID Numbers: 08-209
Study First Received: February 10, 2009
Results First Received: June 27, 2016
Last Updated: October 31, 2016