Lidocaine and Outpatient Gynecologic Laparoscopy

Completed · Not applicable · Has a placebo group

Conditions studied: Pain

In brief

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?

Key facts

Study ID

NCT01250002

Run by

Northwestern University

People needed

70

Starts

2010-11-01

Expected to finish

2011-10-01

Last updated by the study team

2014-06-26

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients undergoing outpatient laparoscopic gynecologic surgery
• American society of anesthesiologists class (ASA) Physical status (PS) I and II
• Age between 18 and 64 years
• Fluent in English
• Body mass index (BMI) less than 35

You may not qualify if…

• History of allergy to local anesthetics
• History of chronic opioid use
• Pregnant patients
• Body Mass Index (BMI) greater than 35
• History of electrocardiogram (EKG) abnormalities
• Hepatic Impairment
• History of congestive heart failure
• Electrocardiogram (EKG) abnormalities
• History of heart block (subject with history of heart block)
• Current use of anti-arrhythmic medications
• Drop -Outs:
• Patient or surgeon request
• Conversion of the surgery from laparoscopic to open

Where it is running

• Prentice Womens Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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