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OpenTrials
Completed

NCT Number: NCT01944098

Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.

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Key information

Conditions

Bariatric Surgical Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients between the ages of 18-65 years old
  • BMI ≥ 40 kg/m2, ≤ 60 kg/m2
  • Undergoing a primary laparoscopic RYGB by Dr. Murr
  • Agree to be followed 24 hours postoperatively
  • Normal K+ and Mg++ serum levels

Exclusion criteria

  • BMI less than 40 kg/m2, > 60 kg/m2
  • Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr
  • Allergy to lidocaine
  • Allergy to hydromorphone or ketorolac
  • Allergy to corn or amide anesthetics
  • Use of (thioridizine)
  • Pregnancy
  • Abnormalities of ALT or AST
  • Intra-operative diagnosis of cirrhosis or portal hypertension
  • Intraoperative complications per surgeon
  • Intraoperative extensive adhesions per surgeon
  • Chronic pain syndrome and chronic use of narcotics
  • Severe back pain secondary to degenerative joint disease

Treatment and study plan

Lidocaine

Drug

Placebo

Drug

Primary outcomes

  1. Postoperative Pain

    Time frame: 6 hours post-surgery

    Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain

  2. Postoperative Pain

    Time frame: 12 hours post-surgery

    Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting

  3. Postoperative Pain

    Time frame: 18 hours post-surgery

    Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting

  4. Postoperative Pain

    Time frame: 24 hours post-surgery

    Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 17, 2013
Registry last updated
Oct 26, 2017

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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