NCT02821169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for phase_3 pain

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 22, 2025

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

June 29, 2016

Last Update Submit

December 15, 2025

Conditions

Pain

Keywords

sinus surgerysphenopalatin ganglionropivacainelocal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    Measure the intensity pain, in the group treated with Ropivacaine.

    at the 2 postoperative hours

Secondary Outcomes (4)

  • Analgesics consumption orally

    during the 7 days post-surgery

  • Administration of analgesics by parenteral route

    at the 2 postoperative hours

  • Visual analog scale for the intensity postoperative pain

    at the 4 and at the 6 postoperative hours

  • Visual analog scale for the during postoperative pain

    At Morning and evening between the 1 and 7 days post surgery

Study Arms (2)

saline solution 0.9%

PLACEBO COMPARATOR

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

Drug: saline solution 0.9%

ropivacaine (2mg/ml)

ACTIVE COMPARATOR

injection of ropivacaine in the sphenopalatine area in both nasal fossa

Drug: ropivacaine

Interventions

ropivacaineDRUG

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

Also known as: NAROPEINE
ropivacaine (2mg/ml)
saline solution 0.9%DRUG

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

Also known as: NaCL 0.9% injectable
saline solution 0.9%

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Related Publications (1)

  • 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.

    PMID: 34013619RESULT

MeSH Terms

Conditions

Pain

Interventions

RopivacaineSaline SolutionInjections

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Goeffrey Mortuaire, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

April 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

December 22, 2025

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)