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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Feeding Disorders

Interventions

Type	Name	Description
DRUG	Lidocaine	Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.
DRUG	Ropivacaine	Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.

Timeline

• Start date: 2020-10-27
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2020-01-31
• Last updated: 2024-01-31

Locations

2 sites across 1 country: France