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Efficacy and safety of intravenous lidocaine versus placebo associated with intrathecal morphine analgesia in major digestive or abdominal surgery
EU CTIS ID: 2025-521206-18-00
What this study is testing
To assess the superiority of IV lidocaine combined with morphine rachi anaesthesia compared with placebo combined with morphine rachi anaesthesia, in reducing morphine consumption postoperatively at 48 hours, in patients undergoing major digestive or abdominal surgery under laparotomy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynaecological, oesophageal, gastric, duodenal, small intestine, etc.)
- Scheduled intervention
- Laparotomy
- Patient in agreement with rachi morphine anaesthesia
- Membership of a social security scheme
You likely can't join if
- Emergency surgery
- Severe liver failure
- Morphine allergy
- Allergy to lidocaine
- Gabapentinoids: pregabalin (Lyrica), gabapentin
- Patient taking part in another clinical trial, or in a period of exclusion from another clinical trial
See the full eligibility criteria
- Age ≥ 18 years
- Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynaecological, oesophageal, gastric, duodenal, small intestine, etc.)
- Scheduled intervention
- Laparotomy
- Patient in agreement with rachi morphine anaesthesia
- Membership of a social security scheme
- Signed informed consent
- Emergency surgery
- Severe liver failure
- Morphine allergy
- Allergy to lidocaine
- Gabapentinoids: pregabalin (Lyrica), gabapentin
- Patient taking part in another clinical trial, or in a period of exclusion from another clinical trial
- Inability to understand information relating to the study (for linguistic, psychological or cognitive reasons, or due to a lack of literacy skills)
- Women who are or may become pregnant (of childbearing age, without effective contraception) or who are breast-feeding
- Patient deprived of liberty or under guardianship or unable to give consent
- Rhythm disorder at risk of sudden death (e.g. Brugada syndrome)
- Flecaine as usual treatment
- Chronic pain with level II or III analgesics
- Contraindication to non-steroidal anti-inflammatory drugs: history of peptic ulcer disease, stage 3 A renal failure or more (DFG according to CKD EPI < 60 ml/min).
- Previous bradycardia and/or known conduction disorder (atrioventricular block) / Pacemaker
- Unstable coronary
- Myocardial infarction <6 months
- Severe cardiocirculatory insufficiency
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.