Trial Evaluating the Efficacy of the Combination of ROpivacaine With

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04250805
Study type	Interventional
Source	Centre Hospitalier Universitaire de Saint Etienne
Contact
Status	Terminated
Phase	Phase 2
Start date	October 27, 2020
Completion date	January 23, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05346796` - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial	N/A
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT04867850` - Effect of Behavioral Nudges on Serious Illness Conversation Documentation	N/A
Enrolling by invitation	`NCT04086251` - Remote Electronic Patient Monitoring in Oncology Patients	N/A
Completed	`NCT01285037` - A Study of LY2801653 in Advanced Cancer	Phase 1
Completed	`NCT00680992` - Study of Denosumab in Subjects With Giant Cell Tumor of Bone	Phase 2
Completed	`NCT00062842` - Study of Irinotecan on a Weekly Schedule in Children	Phase 1
Active, not recruiting	`NCT04548063` - Consent Forms in Cancer Research: Examining the Effect of Length on Readability	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT04349293` - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways	N/A
Terminated	`NCT02866851` - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy	N/A
Active, not recruiting	`NCT05304988` - Development and Validation of the EFT for Adolescents With Cancer
Completed	`NCT00340522` - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting	`NCT04843891` - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Completed	`NCT03109041` - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source	Phase 1
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A
Terminated	`NCT01441115` - ECI301 and Radiation for Advanced or Metastatic Cancer	Phase 1
Recruiting	`NCT06206785` - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting	`NCT05318196` - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy — GASTROXY

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms