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

NCT ID: NCT04250805

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2024-01-23

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.

Conditions

Cancer; Feeding Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lidocaine

Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.

Lidocaine and Ropivacaine

Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.

Ropivacaine

Intervention Type: DRUG

Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.

Interventions

Lidocaine

Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.

Intervention Type: DRUG

Ropivacaine

Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Major patient;
• Having an indication for placement of PRG (percutaneous radiological gastrostomy);
• Patient hospitalized for a minimum of 24 hours post gastrostomy;

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Etievent, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie Lucien Neuwirth

Locations

CHU de Saint-Etienne

Saint-Priest-en-Jarez, , France

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Countries

France

Other Identifiers

2019-004835-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2019-1201

Identifier Type: -

Identifier Source: org_study_id