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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05368753
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 3.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Surgery by Laparotomy; Thoracic Epidural Analgesia; Analgesia; Lidocaine Adverse Reaction	Other: Blood sample; Drug: Lidocain; Drug: ropivacaine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
• Actual Study Start Date: Mar 9, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: thoracic epidural analgesia 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

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.; Drug: 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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,

3. blood lidocaine and ropivacaine concentration (micrograms/ml) [at 2 hours]

   lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,

4. blood ropivacaine concentration (micrograms/ml) [at 24 hours]

   ropivacaine blood sample 24h after the infusion of the TEA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Abdominal surgery by laparotomy

Exclusion Criteria:

• laparoscopic abdominal surgery,

• TEA contraindication,

• ropivacaine contraindication

• intravenous lidocaine contraindication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT05368753
• Other Study ID Numbers: PI2021_843_0197
• First Posted: May 10, 2022
• Last Update Posted: May 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire, Amiens: Abdominal surgery by laparotomy; thoracic epidural analgesia; Analgesia; Lidocaine Adverse Reaction
• Additional relevant MeSH terms: Agnosia; Lidocaine; Ropivacaine

Study Results

No Results Posted as of May 10, 2022