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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05368753
Other study ID # PI2021_843_0197
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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