Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Cancérologie de la Loire
• Treatments: Lidocaine; Ropivacaine

Criteria

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.