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Intraoperative Lidocaine Infusion for Analgesia (ILIA)

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Contents

clinicaltrials.gov/study/NCT00382499
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT003824990
Trial Recruitment Size
930
Trial Sponsor
‌
University of Ottawa
0
Clinical Trial Start Date
2006
0
Primary Completion Date
2008
0
Study Completion Date
2008
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Not Applicable0
Participating Facility
The Ottawa Hospital
The Ottawa Hospital
0
Official Name
A Prospective Evaluation of the Addition of Intraoperative Intravenous Lidocaine Infusion to General Anesthetic in Total Abdominal Hysterectomy0
Last Updated
September 10, 2009
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Outcomes Assessor0
Investigator0
Care Provider0
Participant0

Other attributes

Intervention Treatment
Lidocaine Intravenous Infusion0
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.

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