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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004835-22 | EudraCT Number |
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Difficulties in recruiting patients
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| Name | Class |
|---|---|
| Institut de Cancérologie de la Loire | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance |
|
| Lidocaine and Ropivacaine | Experimental | Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
|
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Inclusion criteria :
Non-inclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Etievent, MD | Institut de Cancérologie Lucien Neuwirth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Priest-en-Jarez | 42270 | France | |||
| Institut de Cancérologie Lucien Neuwirth |
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| Ropivacaine | Drug | Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance. |
|
| 10 days |
| 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 |
| 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 |
| Saint-Priest-en-Jarez |
| 42270 |
| France |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001068 | Feeding and Eating Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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