Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

Obesity Clinical Trial

— SPIRAL  

Official title:

Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525016
• Other study ID #: 69HCL15_0057
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2015
• Last updated: August 2, 2017
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery.

Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use.

Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe.

Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient.

Investigators get approbation of local ethic committee for this work.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

Inclusion Criteria:

• Adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy

• Body mass index > = 40 kg/m2

• Informed consent signed

• Patient treated with intravenous administration of lidocaine

Exclusion Criteria:

• Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria)

• Concomitant use of beta blocker and others anti arrhythmic drugs

• Cardiac or hepatic insufficiency

• Pregnancy

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Intervention

Biological:
• Blood sampling

Drug:
• Lidocaine

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Département d'anesthésie réanimation	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasmatic concentration of lidocaine	Blood samples will be removed by the peripheral catheter or direct venous puncture with other blood sample usually performed during post-operative period.; First sample will be taken after initial bolus (ie 10 min after initiation of perfusion), second at 20 min, third at 30 min. The fourth and fifth samples will be taken after change of posology (from 2 to 1 mg/kg/h at the end of surgery) and at the end of administration. The sixth sample will be performed the day after the end of administration.	From bolus to day 1 after cessation of administration
Secondary	occurence of adverse events related to lidocaine use	neurologic (seizure, dysgeusia, dizziness) or cardiologic events (atrio ventricular block, ventricular rhythm disorder) will be assessed after surgery, during hospitalization in post-operative room or intensive care unit.	Up to 2 days after surgery