Cancer Clinical Trial
— GASTROXYOfficial 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
Verified date | January 2024 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 17 |
Est. completion date | January 23, 2024 |
Est. primary completion date | January 23, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Saint-Etienne | Saint-Priest-en-Jarez | |
France | Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Institut de Cancérologie de la Loire |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of Pain | Two points diminution for maximal pain felt during a twenty four hours after percutaneous gastrostomy under radiological guidance. It will be measured with a visual analogue scale starting at zero for no pain and ending at ten for maximal pain felt. | 24 hours | |
Secondary | Level of Anxiety and Depression | Hospital Anxiety and Depression scores will be reported and analysed for each patient. This scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others relate to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be offered for each of the scores (A and D):
7 or less: absence of symptoms; 8 to 10: doubtful symptomatology; 11 and more: certain symptomatology. |
10 days | |
Secondary | Level of quality of life | Brief Pain Inventory scores will be reported to evaluate the level of the patients' quality of life. For each question, score is comprised between 0 and 10, with 0 meaning no pain or no resounding on life activity, and 10 meaning the worst pain ever, and the worst resounding on life activity. | 10 days | |
Secondary | Level of satisfaction | Patients' satisfaction about their analgesic care will be reported with a visual analogue scale starting at zero meaning no satisfaction, and ending at ten meaning the highest satisfaction possible. | 10 days |
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