NCT01944098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

October 26, 2017

Completed
Last Updated

October 26, 2017

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

August 12, 2013

Results QC Date

December 2, 2015

Last Update Submit

October 25, 2017

Conditions

Bariatric Surgical Pain

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Placebo

ACTIVE COMPARATOR

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

Drug: Placebo

Interventions

LidocaineDRUG
Lidocaine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Enrico Camporesi MD
Organization
TeamHealth Anesthesia
ecampore@health.usf.edu
813-844-7170

Study Officials

  • Rachel Karlnoski, PhD

    Florida Gulf-to-Bay Anesthesiology

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

September 17, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

October 26, 2017

Results First Posted

October 26, 2017

Record last verified: 2015-12

Locations

US(1)