Lidocaine and Outpatient Gynecologic Laparoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01250002
First received: November 27, 2010
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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?


Condition Intervention
Pain
Drug: Placebo
Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Perioperative Systemic Lidocaine on Quality of Recovery After Outpatient Gynecologic Laparoscopy

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of Recovery 40 Score [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
    Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).


Secondary Outcome Measures:
  • Opioid Consumption (Morphine Equivalents) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    opioid consumption (morphine equivalents)post operatively


Enrollment: 70
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine
Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter
Drug: Lidocaine
Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter
Placebo Comparator: Placebo
Placebo will receive the same volume of saline infusion.
Drug: Placebo
Placebo will receive the same volume of saline infusion.

Detailed Description:

70 subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers. Group A (study group) will receive lidocaine. Group B (control group) will receive the same volume of saline infusion. The study drugs will be prepared by one of the investigators in the study. Subjects will be recruited up to 21 days prior to surgery.They will be premedicated with intravenous (IV) midazolam 0.04 mg/kg. Routine ASA monitors will be applied. Anesthesia will be induced with remifentanil infusion started at 0.1 mcg/kg/minute titrated to keep blood pressure within 20% of the baseline and propofol 1.0 -2.0 mg/kg. Group A will receive lidocaine 1.5mg/kg bolus and Group B the equivalent volume of saline. Subjects will be monitored with a 5 lead EKG throughout the lidocaine administration and if any arrhythmia is detected. The study drug will be stopped and investigators unblinded.

Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg) or succinylcholine (1-2mg /kg). Immediately after the induction, group A will receive lidocaine infusion (2 mg/kg/hr IV). Group B will receive the equivalent volume of saline; both infusions will be continued until 1 hour after arrival in the PACU. Anesthesia will be maintained with desflurane titrated to maintain a bispectral index (BIS) between 40-60 , remifentanil infusion started at 0.1mcg/kg/min titrated to keep blood pressure within 20 % of baseline values , and rocuronium that will be administered at the discretion of the anesthesiologist. Upon termination of the surgery, neuromuscular blockade will be antagonized with a combination of neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. Ondansetron 4 mg IV will be administered to prevent postoperative nausea and vomiting. Subject will be evaluated for pain in the OR after extubation, using a numeric rating scale, if pain greater than 4/10 they will receive hydromorphone (10 mcg/kg IV). In PACU, subjects will receive IV hydromorphone in divided doses as needed to achieve a verbal rating score for pain <4 out of 10 and they will be evaluated every 15 minutes .They will also receive metoclopramide (20 mg IV ) as rescue antiemetic in PACU. Discharge readiness will be assessed by a PACU nurse using the modified Post Anesthesia Discharge Scoring System (MPADSS) score every 15 minutes for about 3 hours or until ready for discharge.The primary and secondary outcomes will be assessed by an independent observer who will be blinded to group allocation. Study personnel will contact the subject at 24 hours to assess well being, (nausea, vomiting and opioid consumption. Subject will be contacted by telephone by the study staff and will complete the Modified Quality of Recovery 40 (MQOR40) at 24 hours post surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250002

Locations
United States, Illinois
Prentice Womens Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio De Oliveira, MD Northwestern University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01250002     History of Changes
Other Study ID Numbers: STU00025240
Study First Received: November 27, 2010
Results First Received: March 5, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pain
MQOR 40
Lidocaine
Gynecologic
Surgery
Laparoscopic

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014