Intraoperative Lidocaine Infusion for Analgesia (ILIA)

NCT00382499 | Completed

• 1 other identifier: #2006512-01H
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of intravenous lidocaine infusion administered during general anesthesia in:

1. 1.Reducing length of hospital stay following total abdominal hysterectomy
2. 2.Reducing postoperative analgesic requirement following total abdominal hysterectomy.
3. 3.Length of hospital stay
4. 4.Total opioid use at 48 hours postoperatively
5. 5.Intraoperative data: BIS scores (to control depth of anesthesia); intraoperative serum lidocaine levels; intraoperative opioid use
6. 6.Opioid use in the recovery room
7. 7.Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours
8. 8.Oral pain controlling medication use up to 48 hours postoperatively if IV PCA discontinued before 48 hours
9. 9.Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days post-operatively
10. 10.Incidence of side effects that can be attributed to local anesthetic toxicity
11. 11.Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively
12. 12.Time of first flatus and first bowel movement.

Conditions

Elective Total or Subtotal Abdominal Hysterectomy

Keywords

Intravenous Lidocaine; Lidocaine Infusion; Total Abdominal Hysterectomy; Analgesia; Anesthesia; Adjunct

Outcome Measures

Primary Outcomes (2)

• Length of hospital stay

• Total opioid use at 48 hours postoperatively

Secondary Outcomes (10)

• Intraoperative data: BIS scores (to control depth of anesthesia)

• Intraoperative serum lidocaine levels

• Intraoperative opioid use

• Opioid use in the recovery room

• Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours;

Study Arms (1)

Lidocaine

EXPERIMENTAL

IV lidocaine in OR as described in methods

Drug: Lidocaine Intravenous Infusion

Interventions

Lidocaine Intravenous Infusion DRUG

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

Lidocaine

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• Bryson GL, Charapov I, Krolczyk G, Taljaard M, Reid D. Intravenous lidocaine does not reduce length of hospital stay following abdominal hysterectomy. Can J Anaesth. 2010 Aug;57(8):759-66. doi: 10.1007/s12630-010-9332-2. Epub 2010 Jun 8.

  PMID: 20532723 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ILIA Charapov, MD

  The Ottawa Hospital, Dept of Anesthesia

  PRINCIPAL INVESTIGATOR

• Greg Bryson, MD

  The Ottawa Hospital, Dept of Anesthesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2006
• First Posted: September 29, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 10, 2009

Record last verified: 2009-09

Locations

CA (1)