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

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ropivacaine
saline solution 0.9%
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring sinus surgery, sphenopalatin ganglion, ropivacaine, local anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU, Hôpital Claude Huriez

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

saline solution 0.9%

ropivacaine (2mg/ml)

Arm Description

injection of saline solution in the sphenopalatine area in both nasal fossa

injection of ropivacaine in the sphenopalatine area in both nasal fossa

Outcomes

Primary Outcome Measures

Visual analog scale
Measure the intensity pain, in the group treated with Ropivacaine.

Secondary Outcome Measures

Analgesics consumption orally
patient-controlled administration
Administration of analgesics by parenteral route
patient-controlled administration
Visual analog scale for the intensity postoperative pain
patient-controlled administration
Visual analog scale for the during postoperative pain
self-assessment by the patient at home on the information collection book

Full Information

First Posted
June 29, 2016
Last Updated
September 26, 2019
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02821169
Brief Title
Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain
Acronym
ROPI_POSTOP
Official Title
Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
sinus surgery, sphenopalatin ganglion, ropivacaine, local anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline solution 0.9%
Arm Type
Placebo Comparator
Arm Description
injection of saline solution in the sphenopalatine area in both nasal fossa
Arm Title
ropivacaine (2mg/ml)
Arm Type
Active Comparator
Arm Description
injection of ropivacaine in the sphenopalatine area in both nasal fossa
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Other Intervention Name(s)
NAROPEINE
Intervention Description
injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach
Intervention Type
Drug
Intervention Name(s)
saline solution 0.9%
Other Intervention Name(s)
NaCL 0.9% injectable
Intervention Description
injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach
Primary Outcome Measure Information:
Title
Visual analog scale
Description
Measure the intensity pain, in the group treated with Ropivacaine.
Time Frame
at the 2 postoperative hours
Secondary Outcome Measure Information:
Title
Analgesics consumption orally
Description
patient-controlled administration
Time Frame
during the 7 days post-surgery
Title
Administration of analgesics by parenteral route
Description
patient-controlled administration
Time Frame
at the 2 postoperative hours
Title
Visual analog scale for the intensity postoperative pain
Description
patient-controlled administration
Time Frame
at the 4 and at the 6 postoperative hours
Title
Visual analog scale for the during postoperative pain
Description
self-assessment by the patient at home on the information collection book
Time Frame
At Morning and evening between the 1 and 7 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goeffrey Mortuaire, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34013619
Citation
Morisse M, Rysman B, Szymanski C, Fackeure R, Mouawad F, Mortuaire G. A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2021 Sep;11(9):1384-1386. doi: 10.1002/alr.22804. Epub 2021 May 19. No abstract available.
Results Reference
derived

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

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