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Intravenous Lidocaine in Bariatric Surgery. (XYLOBAR)
This study is not yet open for participant recruitment.
Verified May 2017 by University Hospital, Caen
Sponsor:
University Hospital, Caen
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT03211455
First received: May 31, 2017
Last updated: July 6, 2017
Last verified: May 2017
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Purpose
Although peroperative intravenous lidocaine has been shown to be useful in early recovery after colorectal surgery, its beneficial effect on the specific population of obese patients scheduled for bariatric surgery remained unknown.
Investigators hypothesized that peroperative intravenous lidocaine could decrease postoperative opioid consumption and improve postoperative recovery
| Condition | Intervention | Phase |
|---|---|---|
| Morbid Obesity Bariatric Surgery Candidate | Drug: Lidocaine Drug: isotonic saline | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study |
Resource links provided by NLM:
Further study details as provided by University Hospital, Caen:
Primary Outcome Measures:
- oxycodone consumption [ Time Frame: three days following surgery ]total postoperative (until day 3) oxycodone consumption (mg)
Secondary Outcome Measures:
- lidocaine plasma concentration [ Time Frame: during post anesthesia care unit stay (1 day) ]lidocaine plasma concentration measured at the end of infusion
- hospital discharge check list [ Time Frame: three days following surgery ]recovery (in days) which enable discharge from hospital
- postoperative pain [ Time Frame: three days following surgery ]postoperative pain intensity (visual analogue scale)
- nausea and vomiting [ Time Frame: three days following surgery ]proportion of patients with and without postoperative nausea and vomiting
- intestinal transit recovery [ Time Frame: three days following surgery ]duration (in days) of postoperative intestinal palsy
- hospital length of stay [ Time Frame: through hospital discharge (an average of 1 week) ]hospital length of stay
| Estimated Enrollment: | 180 |
| Anticipated Study Start Date: | August 1, 2017 |
| Estimated Study Completion Date: | May 1, 2019 |
| Estimated Primary Completion Date: | February 1, 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
intravenous isotonic saline administration : bolus of 0.075 ml/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (0.1 ml/kg/h, adjusted body weight) until the end of surgery decrease to 0.05 ml/kg (adjusted body weight) during 60 min in post anesthesia care unit. Speed of infusion were calculated to be equivalent to that of lidocaine speed of injection. |
Drug: isotonic saline
intravenous isotonic saline
Other Name: saline
|
|
Experimental: Lidocaine
Intravenous Lidocaine (20mg/ml) : bolus of 1.5 mg/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (2.0 mg/kg/h, adjusted body weight) until the end of surgery decrease to 1.0 mg/kg (adjusted body weight) during 60 min in post anesthesia care unit.
|
Drug: Lidocaine
intravenous lidocaine versus placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- scheduled bariatric surgery
Exclusion Criteria:
- any contra-indication for lidocaine administration
- pregnancy
- ASA class 4
- psychiatric disorder
- chronic opioid consumption
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211455
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211455
Contacts
| Contact: fabien chaillot | +33 2 31 06 57 81 | chaillot-f@chu-caen.fr | |
| Contact: fabien chaillot | +33 2 31 06 57 81 |
Locations
| France | |
| University Hospital of Caen | |
| Caen, France, 14033 | |
Sponsors and Collaborators
University Hospital, Caen
More Information
| Responsible Party: | University Hospital, Caen |
| ClinicalTrials.gov Identifier: | NCT03211455 History of Changes |
| Other Study ID Numbers: |
17-014 |
| Study First Received: | May 31, 2017 |
| Last Updated: | July 6, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by University Hospital, Caen:
|
bariatric surgery rehabilitation lidocaine |
Additional relevant MeSH terms:
|
Obesity, Morbid Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Lidocaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 11, 2017