Status:
COMPLETED
Intraoperative Lidocaine Infusion for Analgesia (ILIA)
Lead Sponsor:
University of Ottawa
Conditions:
Elective Total or Subtotal Abdominal Hysterectomy
Eligibility:
FEMALE
30-70 years
Phase:
NA
Brief 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 hyster...
Detailed Description
Provide the rationale for the study (see list of references attached separately). Provide the rationale for the study (see list of references attached separately). Adequate postoperative pain contro...
Eligibility Criteria
Inclusion
- Patients undergoing elective total abdominal hysterectomy at The Ottawa Hospital and able to give informed consent.
- Plus:
- Age 30-69 inclusive;
- ASA (American Society of Anesthesiologists) class I or II patient: (I - healthy with no systemic disease, II - systemic disease with no functional limitation);
- Body Mass Index (BMI) of 18.5-30.
Exclusion
- 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:
- Patients under age 30 or over age 70;
- 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);
- Obese patients (BMI\>30) or undernourished (BMI\<18.5) (9);
- Unable to use patient controlled analgesia;
- Any history of liver dysfunction;
- Renal insufficiency defined as a creatinine clearance \<50mL/min as calculated using the Cockroft-Gault formula (11);
- History of seizure disorder;
- Hypersensitivity or allergy to amide type local anesthetics;
- Hypersensitivity or allergy to any of the following opiods: morphine, hydromorphone, meperidine, fentanyl;
- Any chronic pain syndromes or opioid use greater than once per week.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00382499
Start Date
November 1 2006
End Date
December 1 2008
Last Update
September 10 2009
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6