Clinical trial · Interventional
Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties in recruiting patients
Summary
Brief summary (as posted)
Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Feeding Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lidocaine | Drug | — | UNRESOLVED |
| Ropivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lidocaine
- description
- Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance
- interventionNames
- Drug: Lidocaine
- type
- EXPERIMENTAL
- label
- Lidocaine and Ropivacaine
- description
- Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
- interventionNames
- Drug: Lidocaine
- Drug: Ropivacaine
Primary outcomes (1)
- measure
- Level of Pain
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria : * Major patient; * Having an indication for placement of PRG (percutaneous radiological gastrostomy); * Patient hospitalized for a minimum of 24 hours post gastrostomy; Non-inclusion criteria : * Pregnant or lactating woman; * Legal incapacity or limited legal capacity. Medical or psychological conditions which do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9); * Not knowing how to read and / or write French; * Allergy and / or known hypersensitivity to lidocaine and / or ropivacaine or to other local anesthetics with amide bond or to one of the excipients; * Recurrent porphyrias (genetic, hereditary diseases affecting the production of hemoglobin); * Patient on beta blockers during the installation of PRG (Percutaneous Radiological Gastrostomy); * Indication of gastrostomy button placement.
References
Publications (0)
Data not yet available