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Lidocaine and Outpatient Gynecologic Laparoscopy

NCT01250002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-06-26

Study results available
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Summary

Although ambulatory gynecological laparoscopy is considered to be a minimally invasive surgical procedure, only 60% of patients undergoing this procedure are satisfied with postoperative pain control. Postoperative pain can lead to physiological, immunological and psychological derangements in patients.It also has been shown to be the most common cause of hospital admission after outpatient surgery.

Opioids constitute the most commonly used pain management strategy after surgery, however they have many undesirable side effects including nausea, vomiting and respiratory depression. Different strategies have been developed to decrease the amount of opioid required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown to be effective. Systemic administration of lidocaine has been shown to decrease opioid consumption, improve recovery of bowel function and promote a better recovery after inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory properties. It also has an excellent safety profile when give by a low-dose infusion.

The improvement of surgical technique and anesthesia care has made major adverse outcomes infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery has become an important outcome in several studies. The patient's capacity to return to his normal activities is one of the most important sign of a successful outpatient procedure and it has significant economic implications.

Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful outcome measure to assess the impact on changes in health care delivery, but anesthesia studies underutilize this instrument.

The research question for the study is; does the use of systemic perioperative lidocaine improve quality of recovery after outpatient laparoscopy?

Conditions

Interventions

DRUG

Placebo

Placebo will receive the same volume of saline infusion.

DRUG

Lidocaine

Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter

Sponsors & Collaborators

Principal Investigators

  • Gildasio De Oliveira, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01250002 on ClinicalTrials.gov