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Lidocaine and Ketamine in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT00721110
Recruitment Status : Terminated (Futility)
First Posted : July 23, 2008
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE July 21, 2008
First Posted Date  ICMJE July 23, 2008
Results First Submitted Date  ICMJE June 20, 2016
Results First Posted Date  ICMJE July 26, 2017
Last Update Posted Date July 26, 2017
Study Start Date  ICMJE July 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two [ Time Frame: postoperative day 2 ]
The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2008)
The effects of lidocaine (versus placebo) and ketamine (versus placebo) on functional recovery assessed by 6 minute walk test at baseline and on postoperative day two [ Time Frame: Before surgery and postoperative day 2 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 [ Time Frame: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2 ]
    Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.
  • Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 [ Time Frame: intraoperative through postoperative day 2 ]
  • Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day [ Time Frame: 2 hours after surgery, on postoperative day 1 ]
  • Verbal Response Fatigue Score on Postoperative Day 1 [ Time Frame: postoperative day 1 ]
    Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2008)
  • Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2 [ Time Frame: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2 ]
  • Total opioid consumption at PACU admission and discharge as well as mornings of postoperative days 1 and 2 [ Time Frame: postoperative day 2 ]
  • Presence or absence of nausea and vomiting after two hours in the PACU and the morning and afternoon of the first postoperative day [ Time Frame: 2 hours after surgery, morning and afternoon on postoperative day 1 ]
  • Verbal response fatigue score on postoperative day 1 [ Time Frame: postoperative day 1 ]
  • 10 ml of venous blood will be sampled for cytokine analysis. [ Time Frame: 2 hours post operatively, 6 and 12 months after surgery ]
  • The patient is observed and timed rising from a chair with armrests and a seating height of 44-47cm, walking 3 meters, turning around, walking back to the chair and sitting down again. (TUG test) [ Time Frame: day 2 postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine and Ketamine in Abdominal Surgery
Official Title  ICMJE Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy
Brief Summary This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.
Detailed Description Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Hysterectomy (& Wertheim)
Intervention  ICMJE
  • Drug: Lidocaine
    Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
  • Drug: Placebo
    Placebo boluses and infusions will be substituted
  • Drug: Ketamine
    Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
  • Drug: Ketamine + Lidocaine
    both Ketamine and Lidocaine will be given
Study Arms  ICMJE
  • Active Comparator: Lidocaine
    Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
    Intervention: Drug: Placebo
  • Active Comparator: Ketamine
    Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
    Intervention: Drug: Ketamine
  • Active Comparator: ketamine + Lidocaine
    both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.
    Intervention: Drug: Ketamine + Lidocaine
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: August 18, 2011)
64
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2008)
128
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than 18 years old and less than 75 years years old
  • Horizontal abdominal incision

Exclusion Criteria:

  • Emergency or urgent procedure
  • Preexisting chronic pain (at any site) requiring treatment
  • Contraindication to any study medication (ketamine or lidocaine)
  • History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
  • Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
  • Seizure disorder requiring medication within past 2 years
  • Planned spinal or epidural anesthesia or analgesia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00721110
Other Study ID Numbers  ICMJE 08-454
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Grady, MD Cleveland Clinic Hillcrest Hospital
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date April 2017

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