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Intraoperative Lidocaine Infusion for Analgesia (ILIA)

This study has been completed.
Sponsor:
Information provided by:
University of Ottawa
ClinicalTrials.gov Identifier:
NCT00382499
First received: September 28, 2006
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of intravenous lidocaine infusion administered during general anesthesia in:

  1. Reducing length of hospital stay following total abdominal hysterectomy
  2. Reducing postoperative analgesic requirement following total abdominal hysterectomy.

Hypothesis:

The addition of an intraoperative lidocaine infusion to a balanced anesthetic technique will result in up to 50% of patients being discharged after postoperative day 2 compared with the current 21%. Also, it will result in a 30% reduction in opiod consumption during the first 48 hours following total abdominal hysterectomy.

Assumption:

Patients in the intervention and control groups will be titrated to approximately equal analgesia because they will self-administer enough pain-controlling medications to make their postoperative pain experience the same.

Primary outcomes:

  1. Length of hospital stay
  2. Total opioid use at 48 hours postoperatively

Secondary outcomes. The following data will be collected and analyzed:

  1. Intraoperative data: BIS scores (to control depth of anesthesia); intraoperative serum lidocaine levels; intraoperative opioid use
  2. Opioid use in the recovery room
  3. Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours
  4. Oral pain controlling medication use up to 48 hours postoperatively if IV PCA discontinued before 48 hours
  5. Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days post-operatively
  6. Incidence of side effects that can be attributed to local anesthetic toxicity
  7. Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively
  8. Time of first flatus and first bowel movement.

Condition Intervention
Elective Total or Subtotal Abdominal Hysterectomy
 Drug: Lidocaine Intravenous Infusion

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: A Prospective Evaluation of the Addition of Intraoperative Intravenous Lidocaine Infusion to General Anesthetic in Total Abdominal Hysterectomy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ottawa:

Primary Outcome Measures:
  • Length of hospital stay
  • Total opioid use at 48 hours postoperatively

Secondary Outcome Measures:
  • Intraoperative data: BIS scores (to control depth of anesthesia)
  • Intraoperative serum lidocaine levels
  • Intraoperative opioid use
  • Opioid use in the recovery room
  • Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours;
  • Oral pain controlling medication use up to 48 hours postoperatively if IV PCA discontinued before 48 hours;
  • Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days post-operatively;
  • Incidence of side effects that can be attributed to local anesthetic toxicity;
  • Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively;
  • Time of first flatus and first bowel movement.

Enrollment: 93
Study Start Date: November 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
IV lidocaine in OR as described in methods
 Drug: Lidocaine Intravenous Infusion
1.5 mg/kg IV bolus on induction, 3 mg/kg/hr infusion from inducation until fascia closure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients undergoing elective total abdominal hysterectomy at The Ottawa Hospital and able to give informed consent.

Plus:

  1. Age 30-69 inclusive;
  2. ASA (American Society of Anesthesiologists) class I or II patient: (I - healthy with no systemic disease, II - systemic disease with no functional limitation);
  3. Body Mass Index (BMI) of 18.5-30.

Exclusion Criteria:

Patients undergoing elective total abdominal hysterectomy at The Ottawa Hospital and unable to give informed consent., unable to provide informed consent, or unable to use patient controlled analgesia.

Plus:

  1. Patients under age 30 or over age 70;
  2. ASA III, IV and V class patients (III - systemic disease causing functional impairment; IV - systemic disease that is a constant threat to life; V - not expected to survive with or without surgery);
  3. Obese patients (BMI>30) or undernourished (BMI<18.5) (9);
  4. Unable to use patient controlled analgesia;
  5. Any history of liver dysfunction;
  6. Renal insufficiency defined as a creatinine clearance <50mL/min as calculated using the Cockroft-Gault formula (11);
  7. History of seizure disorder;
  8. Hypersensitivity or allergy to amide type local anesthetics;
  9. Hypersensitivity or allergy to any of the following opiods: morphine, hydromorphone, meperidine, fentanyl;
  10. Any chronic pain syndromes or opioid use greater than once per week.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382499

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
University of Ottawa
Investigators
Principal Investigator: ILIA Charapov, MD The Ottawa Hospital, Dept of Anesthesia
Study Chair: Greg Bryson, MD The Ottawa Hospital, Dept of Anesthesia
  More Information

No publications provided by University of Ottawa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. ILIA Charapov, University of Ottawa, Departmet of Anesthesiology
ClinicalTrials.gov Identifier: NCT00382499     History of Changes
Other Study ID Numbers: #2006512-01H
Study First Received: September 28, 2006
Last Updated: September 9, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa:
Intravenous Lidocaine
Lidocaine Infusion
Total Abdominal Hysterectomy
 Analgesia
Anesthesia
Adjunct

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

ClinicalTrials.gov processed this record on June 13, 2013