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

Phase 4

Recruiting

• Conditions: Analgesia; Abdominal Surgery by Laparotomy; Lidocaine Adverse Reaction; Thoracic Epidural Analgesia
• Interventions: Other: Blood sample; Drug: Lidocain; Drug: ropivacaine

• Registration Number: NCT05368753
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Abdominal surgery by laparotomy

Exclusion Criteria

• laparoscopic abdominal surgery,
• TEA contraindication,
• ropivacaine contraindication
• intravenous lidocaine contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
thoracic epidural analgesia	Blood sample	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
thoracic epidural analgesia	Lidocain	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
thoracic epidural analgesia	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France