Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

Bariatric Surgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944098
• Other study ID #: Pro00002417
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2013
• Last updated: October 25, 2017
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgical Pain
• Pain, Postoperative

Intervention

Drug:
• Lidocaine

• Placebo

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	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	6 hours post-surgery
Primary	Postoperative Pain	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	12 hours post-surgery
Primary	Postoperative Pain	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	18 hours post-surgery
Primary	Postoperative Pain	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	24 hours post-surgery