Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

Phase 3

Completed

• Conditions: Bariatric Surgical Pain
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT01944098
• Lead Sponsor: University of South Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2015-12
• Results First Submitted: 2015-12-02
• Results First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Results First Posted: 2017-10-26
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Lidocaine	Lidocaine	Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	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

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States