Lidocaine and Ketamine in Abdominal Surgery

This study has been terminated.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00721110
First received: July 21, 2008
Last updated: August 18, 2011
Last verified: August 2011
  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
Hysterectomy
Drug: Lidocaine
Drug: Ketamine
Drug: Lidocaine and Ketamine
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Outcomes Research Consortium:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Total opioid consumption at PACU admission and discharge as well as mornings of postoperative days 1 and 2 [ Time Frame: postoperative day 2 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Verbal response fatigue score on postoperative day 1 [ Time Frame: postoperative day 1 ] [ Designated as safety issue: No ]
  • 10 ml of venous blood will be sampled for cytokine analysis. [ Time Frame: 2 hours post operatively, 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Other Name: Xylocaine
Active Comparator: 2
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: 3
Intravenous Lidocaine and Ketamine Group - Lidocaine and ketamine are administered intravenously throughout surgery and during the 24 hours following surgery
Drug: Lidocaine and Ketamine
At general anesthetic induction intravenous lidocaine (1.5 mg/kg) will be given. Upon induction of anesthesia, lidocaine 2 mg/kg/hour, to a maximum of 200 mg/hour, will be infused. The lidocaine infusion will be reduced to 1.3 mg/kg/hour up to 133 mg/hour at skin closure and discontinued 24 hours postoperatively. Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/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.
Other Name: Xylocaine
Placebo Comparator: 4
A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
Other: placebo
Placebo boluses and infusions will be substituted for the lidocaine and ketamine not 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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721110

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

No publications provided

Responsible Party: Martin Grady, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00721110     History of Changes
Other Study ID Numbers: 08-454
Study First Received: July 21, 2008
Last Updated: August 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
pain control
nausea
surgery recovery

Additional relevant MeSH terms:
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular 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

ClinicalTrials.gov processed this record on September 16, 2014