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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04250805

Collaborator

Institut de Cancérologie de la Loire (Other)

124

Enrollment

Locations

Arms

29.1

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Feeding Disorders	Drug: Lidocaine Drug: Ropivacaine	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 27, 2020

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lidocaine Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance	Drug: Lidocaine Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.
Experimental: Lidocaine and Ropivacaine Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance	Drug: Lidocaine Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance. Drug: Ropivacaine Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.

Arm

Intervention/Treatment

Active Comparator: Lidocaine

Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance

Drug: Lidocaine

Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.

Experimental: Lidocaine and Ropivacaine

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

Drug: Lidocaine

Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.

Drug: Ropivacaine

Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.

Outcome Measures

Primary Outcome Measures

Level of Pain [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 Outcome Measures

Level of Anxiety and Depression [10 days]
Hospital Anxiety and Depression scores will be reported and analysed for each patient. This scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others relate to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be offered for each of the scores (A and D): 7 or less: absence of symptoms; 8 to 10: doubtful symptomatology; 11 and more: certain symptomatology.
Level of quality of life [10 days]
Brief Pain Inventory scores will be reported to evaluate the level of the patients' quality of life. For each question, score is comprised between 0 and 10, with 0 meaning no pain or no resounding on life activity, and 10 meaning the worst pain ever, and the worst resounding on life activity.
Level of satisfaction [10 days]
Patients' satisfaction about their analgesic care will be reported with a visual analogue scale starting at zero meaning no satisfaction, and ending at ten meaning the highest satisfaction possible.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.