Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy

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: NCT02150161
Recruitment Status : Terminated (DSMB estimated futility of the trial and safety risk)
First Posted : May 29, 2014
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
David Torres, Clinica Santa Maria

Tracking Information
First Submitted Date  ICMJE May 26, 2014
First Posted Date  ICMJE May 29, 2014
Last Update Posted Date September 25, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Incidence of postoperative nausea and vomiting in the recovery room [ Time Frame: first 3 postoperative hours ]
  • morphine consumption in the recovery room [ Time Frame: first 3 postopeartive hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Incidence of postoperative nausea and vomiting on day 1 [ Time Frame: 1st postoperative day ]
  • Anesthestic gas consumption [ Time Frame: intraoperative ]
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 Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy
Official Title  ICMJE Fentanyl vs. Lidocaine/Ketamine Infusion for Hip Arthroscopy
Brief Summary The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid Free Anaesthesia
  • Postoperative Analgesia
Intervention  ICMJE
  • Drug: Lidocaine/ ketamine
  • Drug: Fentanyl
Study Arms  ICMJE
  • Experimental: lidocaine/ ketamine infusion
    lidocaine 1mg/Kg bolus, followed by continuous infusion 1 mg/kg/h AND ketamine 1mg/Kg bolus followed by continuous infusion 1 mg/kg/h
    Intervention: Drug: Lidocaine/ ketamine
  • Active Comparator: fentanyl
    iv fentanyl, 3ug/kg bolus
    Intervention: Drug: Fentanyl
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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 24, 2015)
53
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
100
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-65 years old
  • ASA I-II
  • Undergoing elective hip arthroscopy

Exclusion Criteria:

  • Known allergies to study drugs
  • Opioid use 1 month prior to surgery
  • BMI >30
  • Unable to comprehend visual analog scale
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02150161
Other Study ID Numbers  ICMJE 56csm2014001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Torres, Clinica Santa Maria
Study Sponsor  ICMJE Clinica Santa Maria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Torres, MD; MSc Clinica Santa Maria
PRS Account Clinica Santa Maria
Verification Date September 2015

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