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Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

NCT ID: NCT01944098

Last Updated: 2017-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Bariatric Surgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lidocaine

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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Placebo

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Lidocaine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Karlnoski, PhD

Role: STUDY_DIRECTOR

Florida Gulf-to-Bay Anesthesiology

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00002417

Identifier Type: -

Identifier Source: org_study_id