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Clinical trial

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

ID
Name
PI2021_843_0197
Description
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.
Trial arms
Trial start
2022-03-09
Estimated PCD
2023-08-01
Trial end
2023-08-01
Status
Recruiting
Phase
Early phase I
Treatment
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
Arms:
thoracic epidural analgesia
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.
Arms:
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.
Arms:
thoracic epidural analgesia
Size
50
Primary endpoint
Blood lidocaine concentration (micrograms/ml)
30 minutes before the end of surgery
blood lidocaine concentration (micrograms/ml)
at the end of the surgery (assessed up to 2 hours)
blood lidocaine and ropivacaine concentration (micrograms/ml)
at 2 hours
blood ropivacaine concentration (micrograms/ml)
at 24 hours
Eligibility criteria
Inclusion Criteria: * Abdominal surgery by laparotomy Exclusion Criteria: * laparoscopic abdominal surgery, * TEA contraindication, * ropivacaine contraindication * intravenous lidocaine contraindication
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-05-10

1 organization

2 products

4 indications

Organization
Centre Hospitalier Universitaire Amiens
Product
Lidocain
Indication
Abdominal Surgery by Laparotomy
Indication
Epidural Analgesia
Indication
Analgesic
Indication
Lidocaine Adverse Reaction
Product
ropivacaine