Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

University of South Florida

Status and phase: Completed; Phase 3

Conditions: Bariatric Surgical Pain

Treatments: Drug: Lidocaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01944098

Pro00002417

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Lidocaine

Experimental group

Description:

Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr

Treatment:

Drug: Lidocaine

Placebo

Active Comparator group

Description:

Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr

Treatment:

Drug: Placebo