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Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.

Primary Purpose

Pain, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Appendectomy or cholecystectomy surgery

Exclusion Criteria:

  • Allergy to local anesthetics
  • Intolerance to tramadol HCl
  • Patient with peritonitis
  • Pregnant women
  • Surgery without laparoscopy
  • Chronic pain before the operation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Ropivacaïne 0,5%

    NaCl 0,9%

    Arm Description

    3 mg/kg of ropivacaine 0.5% sprayed into the abdominal cavity

    NaCl 0,9% sprayed into the abdominal cavity

    Outcomes

    Primary Outcome Measures

    Patient's pain
    The patient's satisfaction was assessed by visual analog scale, ranging from one (worse outcome )to four (better outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2021
    Last Updated
    December 10, 2021
    Sponsor
    University of Liege
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05173090
    Brief Title
    Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.
    Official Title
    Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    July 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Liege

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ropivacaïne 0,5%
    Arm Type
    Active Comparator
    Arm Description
    3 mg/kg of ropivacaine 0.5% sprayed into the abdominal cavity
    Arm Title
    NaCl 0,9%
    Arm Type
    Placebo Comparator
    Arm Description
    NaCl 0,9% sprayed into the abdominal cavity
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery
    Intervention Description
    Visual analog scale 15 min after arrival in the recovery room, then H+4, H+6, H+12, H+24 and one week after the operation
    Primary Outcome Measure Information:
    Title
    Patient's pain
    Description
    The patient's satisfaction was assessed by visual analog scale, ranging from one (worse outcome )to four (better outcome
    Time Frame
    During appendectomy and cholecystectomy surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Appendectomy or cholecystectomy surgery Exclusion Criteria: Allergy to local anesthetics Intolerance to tramadol HCl Patient with peritonitis Pregnant women Surgery without laparoscopy Chronic pain before the operation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin Javillier, MD
    Phone
    +32498573882
    Email
    javillier.benjamin@hotmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.

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