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Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01983020
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

Tracking Information
First Submitted Date  ICMJE November 7, 2013
First Posted Date  ICMJE November 13, 2013
Results First Submitted Date  ICMJE August 18, 2014
Results First Posted Date  ICMJE May 15, 2017
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE April 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
Pain Intensity [ Time Frame: postoperative day 1 - 3 ]
The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Pain Intensity [ Time Frame: postoperative day 1 - 3 ]
The primary outcome will be average pain intensity at rest on postoperative day 1 - 3.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
Official Title  ICMJE Randomized Double Blind Comparison of Peri-Operative Standard Analgesia With Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
Brief Summary This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Lidocaine
  • Drug: Ketamine
  • Other: Saline
Study Arms  ICMJE
  • Experimental: Ketamine
    Ketamine infused at 0.25 mg/kg/hour.
    Intervention: Drug: Ketamine
  • Experimental: Lidocaine
    Lidocaine infused at 0.5 mg/kg/hour.
    Intervention: Drug: Lidocaine
  • Experimental: Ketamine and Lidocaine
    Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
    Interventions:
    • Drug: Lidocaine
    • Drug: Ketamine
  • Placebo Comparator: Placebo
    Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
    Intervention: Other: Saline
Publications * Not Provided

*   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: April 28, 2017)
46
Original Actual Enrollment  ICMJE
 (submitted: November 7, 2013)
55
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Male and Female >/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study

Exclusion Criteria:

Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01983020
Other Study ID Numbers  ICMJE IRB 073-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beth Israel Medical Center
Study Sponsor  ICMJE Beth Israel Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronald Kaplan, MD Beth Israel Medical Center
PRS Account Beth Israel Medical Center
Verification Date April 2017

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