Intraoperative Lidocaine Infusion for Analgesia (ILIA)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ottawa
• Treatments: Lidocaine

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.