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| Sponsored by: |
University of Ottawa |
|---|---|
| Information provided by: | University of Ottawa |
| ClinicalTrials.gov Identifier: | NCT00382499 |
Purpose
Please state clearly the hypothesis to be tested, in lay terms.
Purpose: To evaluate the efficacy of intravenous lidocaine infusion administered during general anesthesia in:
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:
Secondary outcomes. The following data will be collected and analyzed:
| Condition | Intervention |
|---|---|
|
Elective Total Abdomincal Hysterectomy |
Drug: Lidocaine Intravenous Infusion |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Prospective Evaluation of the Addition of Intraoperative Intravenous Lidocaine Infusion to General Anesthetic in Total Abdominal Hysterectomy. |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2006 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients undergoing elective total abdominal hysterectomy at The Ottawa Hospital and able to give informed consent.
Plus:
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:
Contacts and Locations| Contact: ILIA Charapov, MD | 613-2605795 | charapov@rogers.com |
| Contact: Jordan Caveno, MD | jcave013@uottawa.ca |
| Canada, Ontario | |
| The Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Principal Investigator: | Jordan Caveno, MD | The Ottawa Hospital, Dept of Anesthesia |
| Principal Investigator: | ILIA Charapov, MD | The Ottawa Hospital, Dept of Anesthesia |
| Principal Investigator: | Greg Bryson, MD | The Ottawa Hospital, Dept of Anesthesia |
| Principal Investigator: | Dennis Reid, MD | The Ottawa Hospital, Dept of Anesthesia |
More Information
| Study ID Numbers: | #2006512-01H |
| Study First Received: | September 28, 2006 |
| Last Updated: | September 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00382499 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Intravenous Lidocaine Lidocaine Infusion Total Abdominal Hysterectomy |
Analgesia Anesthesia Adjunct |
|
Anesthetics, General Lidocaine Central Nervous System Depressants Anesthetics |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Anesthetics, Local |
|
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Lidocaine Central Nervous System Depressants Anesthetics |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |