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

December 10, 2021 updated by: Benjamin Javillier, MD, University of Liege
Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropivacaïne 0,5%
3 mg/kg of ropivacaine 0.5% sprayed into the abdominal cavity
Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery
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
Placebo Comparator: NaCl 0,9%
NaCl 0,9% sprayed into the abdominal cavity
Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's pain
Time Frame: During appendectomy and cholecystectomy surgery
The patient's satisfaction was assessed by visual analog scale, ranging from one (worse outcome )to four (better outcome
During appendectomy and cholecystectomy surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2022

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

July 30, 2022

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ropicoelio

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Acute

Clinical Trials on Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe