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OpenTrials
Completed

NCT Number: NCT01180660

IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery.

This study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.

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Key information

Conditions

Pain Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I, II,III;
  • BMI > 35 kg/m2,
  • Age between 18-70,
  • Fluent in English,
  • Patients undergoing laparoscopic gastric bypass,
  • EKG within 3 months.

Exclusion criteria

  • History of allergy to local anesthetics,
  • History of chronic opioid use,
  • Pregnant patients,
  • History of EKG abnormalities.

Dropout: Conversion to open, patient or surgeon request.

Treatment and study plan

Lidocaine infusion

Drug

1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period

normal saline

Drug

Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period

Other names: Placebo infusion

Primary outcomes

  1. Quality of Recovery 40 on the Day After Surgery

    Time frame: 24 hours

    Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.

    The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.

Secondary outcomes

  1. 24 Hour Total Opioid Consumption

    Time frame: 24 hours post surgery

    24 hour total opioid consumption using IV morphine equivalents

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2010
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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