Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
Overview
- Phase
- Phase 2
- Intervention
- Lidocaine
- Conditions
- Cancer
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Level of Pain
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lidocaine and Ropivacaine
Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
Intervention: Lidocaine
Lidocaine and Ropivacaine
Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
Intervention: Ropivacaine
Lidocaine
Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance
Intervention: Lidocaine
Outcomes
Primary Outcomes
Level of Pain
Time Frame: 24 hours
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.
Secondary Outcomes
- Level of quality of life(10 days)
- Level of Anxiety and Depression(10 days)
- Level of satisfaction(10 days)