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New treatment option for Laparotomy
Official title Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
ClinicalTrials.gov ID: NCT04985695
What this study is testing
What is Epidural analgesia?
Epidural analgesia is an investigational medicine, being studied as a potential treatment for laparotomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy
- Have given an informed written consent
- Able to read and understand french language
- Affiliation to a social security system
You likely can't join if
- Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA...
- Epidural analgesia contraindication
- With impossibility to set up bilateral rectus sheath block
- Participation in another clinical study
- Pregnant women
- Patients deprived of their liberty by a judicial or administrative decision,
See the full eligibility criteria
- ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy
- Have given an informed written consent
- Able to read and understand french language
- Affiliation to a social security system
- Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal...
- Epidural analgesia contraindication
- With impossibility to set up bilateral rectus sheath block
- Participation in another clinical study
- Pregnant women
- Patients deprived of their liberty by a judicial or administrative decision,
- Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code
The study team makes the final eligibility decision.
Where it's taking place
- Metz, Moselle, France
- Thionville, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Metz, Moselle, France; Thionville, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.