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

NCT ID: NCT02821169

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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sinus surgery sphenopalatin ganglion ropivacaine local anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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saline solution 0.9%

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

Group Type PLACEBO_COMPARATOR

saline solution 0.9%

Intervention Type DRUG

injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach

ropivacaine (2mg/ml)

injection of ropivacaine in the sphenopalatine area in both nasal fossa

Group Type ACTIVE_COMPARATOR

ropivacaine

Intervention Type DRUG

injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach

Interventions

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ropivacaine

injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach

Intervention Type DRUG

saline solution 0.9%

injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach

Intervention Type DRUG

Other Intervention Names

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NAROPEINE NaCL 0.9% injectable

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Goeffrey Mortuaire, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHRU, Hôpital Claude Huriez

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 34013619 (View on PubMed)

Other Identifiers

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2013-004410-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013_07

Identifier Type: -

Identifier Source: org_study_id