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

NCT04250805 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-01-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lidocaine

Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.

DRUG

Ropivacaine

Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.

Sponsors & Collaborators

  • Institut de Cancérologie de la Loire

    collaborator OTHER
  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Guillaume Etievent, MD · Institut de Cancérologie Lucien Neuwirth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2024-01-23
Completion
2024-01-23

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250805 on ClinicalTrials.gov