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)
Primary Purpose
Cancer, Feeding Disorders
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lidocaine
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Cancer, Gastrostomy, Percutaneous technique, Radiological guidance, Lidocaine, Ropivacaine, Pain
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;
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.
Sites / Locations
- CHU de Saint-Etienne
- Institut de Cancérologie Lucien NeuwirthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lidocaine
Lidocaine and Ropivacaine
Arm Description
Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance
Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
Outcomes
Primary Outcome Measures
Level of Pain
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
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
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
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.
Full Information
NCT ID
NCT04250805
First Posted
January 30, 2020
Last Updated
May 4, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Institut de Cancérologie de la Loire
1. Study Identification
Unique Protocol Identification Number
NCT04250805
Brief 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
Acronym
GASTROXY
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Institut de Cancérologie de la Loire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Feeding Disorders
Keywords
Cancer, Gastrostomy, Percutaneous technique, Radiological guidance, Lidocaine, Ropivacaine, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance
Arm Title
Lidocaine and Ropivacaine
Arm Type
Experimental
Arm Description
Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.
Primary Outcome Measure Information:
Title
Level of Pain
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Level of Anxiety and Depression
Description
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.
Time Frame
10 days
Title
Level of quality of life
Description
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.
Time Frame
10 days
Title
Level of satisfaction
Description
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.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde Maison, MsC
Phone
0477917136
Email
mathilde.maison@icloire.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Etievent, MD
Organizational Affiliation
Institut de Cancérologie Lucien Neuwirth
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Grange, MD
First Name & Middle Initial & Last Name & Degree
Sylvain Grange, MD
First Name & Middle Initial & Last Name & Degree
Rémi Grange, MD
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Etievent, MD
First Name & Middle Initial & Last Name & Degree
Guillaume Etievent, MD
First Name & Middle Initial & Last Name & Degree
Marielle Pailler, MD
First Name & Middle Initial & Last Name & Degree
Marine Dematons, MD
First Name & Middle Initial & Last Name & Degree
Sabine Jardin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
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