Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery (LARA)
Primary Purpose
Abdominal Surgery by Laparotomy, Thoracic Epidural Analgesia, Analgesia
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Blood sample
Lidocain
ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Surgery by Laparotomy focused on measuring Abdominal surgery by laparotomy, thoracic epidural analgesia, Analgesia, Lidocaine Adverse Reaction
Eligibility Criteria
Inclusion Criteria:
- Abdominal surgery by laparotomy
Exclusion Criteria:
- laparoscopic abdominal surgery,
- TEA contraindication,
- ropivacaine contraindication
- intravenous lidocaine contraindication
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
thoracic epidural analgesia
Arm Description
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period
Outcomes
Primary Outcome Measures
Blood lidocaine concentration (micrograms/ml)
Lidocaine blood sample will be performed 30 min before the end of the surgery
blood lidocaine concentration (micrograms/ml)
lidocaine blood sample will be performed at the end of the infusion,
blood lidocaine and ropivacaine concentration (micrograms/ml)
lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,
blood ropivacaine concentration (micrograms/ml)
ropivacaine blood sample 24h after the infusion of the TEA
Secondary Outcome Measures
Full Information
NCT ID
NCT05368753
First Posted
March 14, 2022
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05368753
Brief Title
Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
Acronym
LARA
Official Title
Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period.
Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery.
Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Surgery by Laparotomy, Thoracic Epidural Analgesia, Analgesia, Lidocaine Adverse Reaction
Keywords
Abdominal surgery by laparotomy, thoracic epidural analgesia, Analgesia, Lidocaine Adverse Reaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thoracic epidural analgesia
Arm Type
Experimental
Arm Description
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Lidocaine blood sample 30 min before the end of the surgery Lidocaine blood sample at the end of the infusion lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA Ropivacaine blood sample 24h after the infusion of the TEA
Intervention Type
Drug
Intervention Name(s)
Lidocain
Intervention Description
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end) The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Intervention Description
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.
Primary Outcome Measure Information:
Title
Blood lidocaine concentration (micrograms/ml)
Description
Lidocaine blood sample will be performed 30 min before the end of the surgery
Time Frame
30 minutes before the end of surgery
Title
blood lidocaine concentration (micrograms/ml)
Description
lidocaine blood sample will be performed at the end of the infusion,
Time Frame
at the end of the surgery (assessed up to 2 hours)
Title
blood lidocaine and ropivacaine concentration (micrograms/ml)
Description
lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,
Time Frame
at 2 hours
Title
blood ropivacaine concentration (micrograms/ml)
Description
ropivacaine blood sample 24h after the infusion of the TEA
Time Frame
at 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Abdominal surgery by laparotomy
Exclusion Criteria:
laparoscopic abdominal surgery,
TEA contraindication,
ropivacaine contraindication
intravenous lidocaine contraindication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ottilie Fumery - Trocheris, MD
Phone
03.22.08.91.08
Email
fumery.ottilie@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ottilie FUMERY- TROCHERIS, MD
Email
fumery.ottilie@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Anne Sophie Hurtel Lemaire, MD
First Name & Middle Initial & Last Name & Degree
Sophie Bodeau, MD
First Name & Middle Initial & Last Name & Degree
Youssef Benis, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
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