Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery

Analgesia Clinical Trial

— LARA  

Official title:

Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05368753
• Other study ID #: PI2021_843_0197
• Status: Recruiting
• Phase: Phase 4
• Start date: March 9, 2022
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Ottilie Fumery - Trocheris, MD
• Phone: 03.22.08.91.08
• Email: fumery.ottilie[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Abdominal surgery by laparotomy

Exclusion Criteria:

• laparoscopic abdominal surgery,

• TEA contraindication,

• ropivacaine contraindication

• intravenous lidocaine contraindication

Related Conditions & MeSH terms

• Abdominal Surgery by Laparotomy
• Analgesia
• Lidocaine Adverse Reaction
• Thoracic Epidural Analgesia

Intervention

Other:
• Blood sample
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

Drug:
• Lidocain
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.
• ropivacaine
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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lidocaine concentration (micrograms/ml)	Lidocaine blood sample will be performed 30 min before the end of the surgery	30 minutes before the end of surgery
Primary	blood lidocaine concentration (micrograms/ml)	lidocaine blood sample will be performed at the end of the infusion,	at the end of the surgery (assessed up to 2 hours)
Primary	blood lidocaine and ropivacaine concentration (micrograms/ml)	lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,	at 2 hours
Primary	blood ropivacaine concentration (micrograms/ml)	ropivacaine blood sample 24h after the infusion of the TEA	at 24 hours