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Lidocaine and Ketamine in Abdominal Surgery

This study has been terminated.
(Futility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721110
First Posted: July 23, 2008
Last Update Posted: July 26, 2017
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.
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose
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.

Condition Intervention
Abdominal Hysterectomy (& Wertheim) Drug: Lidocaine Drug: Placebo Drug: Ketamine Drug: Ketamine + Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 64
Study Start Date: July 2008
Study Completion Date: July 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
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.
Placebo Comparator: Placebo
A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
Drug: Placebo
Placebo boluses and infusions will be substituted
Active Comparator: Ketamine
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
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.
Active Comparator: ketamine + Lidocaine
both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.
Drug: Ketamine + Lidocaine
both Ketamine and Lidocaine will be given

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721110


Locations
United States, Ohio
Cleveland Clinic/Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Martin Grady, MD Cleveland Clinic/Hillcrest Hospital
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00721110     History of Changes
Other Study ID Numbers: 08-454
First Submitted: July 21, 2008
First Posted: July 23, 2008
Results First Submitted: June 20, 2016
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Cleveland Clinic:
pain control
nausea
surgery recovery

Additional relevant MeSH terms:
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents