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Intraoperative Lidocaine Infusion for Analgesia (ILIA)

NCT00382499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2009-09-10

No results posted yet for this study

Summary

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.

Conditions

  • Elective Total or Subtotal Abdominal Hysterectomy

Interventions

DRUG

Lidocaine Intravenous Infusion

1.5 mg/kg IV bolus on induction, 3 mg/kg/hr infusion from inducation until fascia closure

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • ILIA Charapov, MD · The Ottawa Hospital, Dept of Anesthesia

  • Greg Bryson, MD · The Ottawa Hospital, Dept of Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00382499 on ClinicalTrials.gov