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

Phase 2

Terminated

• Conditions: Feeding Disorders; Cancer
• Interventions: Drug: Lidocaine; Drug: Ropivacaine

• Registration Number: NCT04250805
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Study Start: 2020-10-27
• Status Verified: 2024-01
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine and Ropivacaine	Ropivacaine	Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance
Lidocaine	Lidocaine	Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance
Lidocaine and Ropivacaine	Lidocaine	Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.

Trial Locations

Locations (2)

CHU de Saint-Etienne; 🇫🇷 Saint-Priest-en-Jarez, France

Institut de Cancérologie Lucien Neuwirth; 🇫🇷 Saint-Priest-en-Jarez, France