Clinical trial NCT04250805: Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
Official title: Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Feeding Disorders
Keywords: Cancer
Gastrostomy
Percutaneous technique
Radiological guidance
Lidocaine
Ropivacaine
Pain
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut de Cancérologie de la Loire
First posted: 2020-01-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Gastrostomy is an intra-gastric nutritional enteral device, allowing the nutritional support for patients presenting oral feeding disorders. Gastrostomy could be put in place by different manners:

* Chirurgical technique or endoscopy: with general anesthesia;
* Percutaneous technique under radiological guidance: allowing local anesthesia. This last one is better tolerated by weak patients, and involves less complication.

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. Indeed, pain felt during the twenty four hours post procedure seems to be the most frequent adverse effect reported by patients.

Pain could decrease significantly when Ropivacaine is added to the reference Xylocaine. Ropivacaine had already proved its efficacy in association with other antalgics.

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.

Eligibility 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.

Primary outcomes:
measure: Level of Pain
timeFrame: 24 hours
Secondary outcomes:
measure: Level of Anxiety and Depression
timeFrame: 10 days
measure: Level of quality of life
timeFrame: 10 days
measure: Level of satisfaction
timeFrame: 10 days
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Guillaume Etievent, MD
role: PRINCIPAL_INVESTIGATOR
References: