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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)

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ClinicalTrials.gov Identifier: NCT04250805
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Level of Pain [ Time Frame: 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 :
  1. Level of Anxiety and Depression [ Time Frame: 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.

  2. Level of quality of life [ Time Frame: 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.

  3. Level of satisfaction [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250805


Contacts
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Contact: Mathilde Maison, MsC 0477917136 mathilde.maison@icloire.fr

Locations
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France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42270
Contact: Guillaume Etievent, MD         
Principal Investigator: Guillaume Etievent, MD         
Sub-Investigator: Marielle Pailler, MD         
Sub-Investigator: Marine Dematons, MD         
Sub-Investigator: Sabine Jardin, MD         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Guillaume Etievent, MD Institut de Cancérologie Lucien Neuwirth
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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT04250805    
Other Study ID Numbers: 2019-1201
2019-004835-22 ( EudraCT Number )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de la Loire:
Cancer
Gastrostomy
Percutaneous technique
Radiological guidance
Lidocaine
Ropivacaine
Pain
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders
Lidocaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action