Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain (ROPI_POSTOP)

September 26, 2019 updated by: University Hospital, Lille

Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.

Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many chronic rhinosinusitis for whom the medical treatment failed. In order to improve the postoperative management of patients treated with ESS, we aim to assess the analgesic action of local injection of ropivacaine in the nasal fossa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized double blind placebo controlled study was designed. Local injection of ropivacaine or placebo was conducted at the end of the surgical procedure in both nasal fossa through endoscopic view in the sphenopalatine region.

Pain was measured in the postoperative course with visual analogic scale in the recovery room and the rhinologic department.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • France
      • Lille, France
        • CHRU, Hôpital Claude HURIEZ

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients requiring endoscopic sinus surgery
  • ASA score 1 or 2
  • patients with health care insurance
  • approved consent

Exclusion Criteria:

  • any sinonasal malignant tumor
  • renal failure, hepatic disorder, respiratory deficiency, cardiovascular diseases
  • neurologic disorders
  • alcohol or drugs addiction
  • preoperative facial pain from an extranasal origin
  • coagulation disorders
  • antidepressive treatment

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: saline solution 0.9%
injection of saline solution in the sphenopalatine area in both nasal fossa
Drug: saline solution 0.9%
injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach
Other Names:
  • NaCL 0.9% injectable
Active Comparator: ropivacaine (2mg/ml)
injection of ropivacaine in the sphenopalatine area in both nasal fossa
Drug: ropivacaine
injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach
Other Names:
  • NAROPEINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: at the 2 postoperative hours
Measure the intensity pain, in the group treated with Ropivacaine.
at the 2 postoperative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesics consumption orally
Time Frame: during the 7 days post-surgery
patient-controlled administration
during the 7 days post-surgery
Administration of analgesics by parenteral route
Time Frame: at the 2 postoperative hours
patient-controlled administration
at the 2 postoperative hours
Visual analog scale for the intensity postoperative pain
Time Frame: at the 4 and at the 6 postoperative hours
patient-controlled administration
at the 4 and at the 6 postoperative hours
Visual analog scale for the during postoperative pain
Time Frame: At Morning and evening between the 1 and 7 days post surgery
self-assessment by the patient at home on the information collection book
At Morning and evening between the 1 and 7 days post surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Goeffrey Mortuaire, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_07
  • 2013-004410-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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