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)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Terminated; Phase 2

Conditions: Cancer; Feeding Disorders

Treatments: Drug: Lidocaine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04250805

2019-004835-22 (EudraCT Number)

2019-1201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Non-inclusion criteria :

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Lidocaine

Active Comparator group

Description:

Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance

Treatment:

Drug: Lidocaine

Lidocaine and Ropivacaine

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Lidocaine