PainPhase 3ROPI_POSTOPNCT02821169
Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain
A Phase 3 study testing ropivacaine and saline solution 0.9% in people with Pain, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- ropivacaine and saline solution 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients requiring endoscopic sinus surgery
- ASA score 1 or 2
- patients with health care insurance
- approved consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Pain
- Being tested
- ropivacaine, saline solution 0.9%
- Keywords
- sinus surgery, sphenopalatin ganglion, ropivacaine, local anesthesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called NAROPEINE
injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach
saline solution 0.9%Drug
Also called NaCL 0.9% injectable
injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach
| Study group | Role | What they receive |
|---|---|---|
| saline solution 0.9% | Placebo comparator | injection of saline solution in the sphenopalatine area in both nasal fossa Receives: Drug: saline solution 0.9% |
| ropivacaine (2mg/ml) | Active comparator | injection of ropivacaine in the sphenopalatine area in both nasal fossa Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Measure the intensity pain, in the group treated with Ropivacaine.
Measured: at the 2 postoperative hours
Secondary outcomes (4)
Analgesics consumption orally
patient-controlled administration
Measured: during the 7 days post-surgery
Administration of analgesics by parenteral route
patient-controlled administration
Measured: at the 2 postoperative hours
Visual analog scale for the intensity postoperative pain
patient-controlled administration
Measured: at the 4 and at the 6 postoperative hours
Visual analog scale for the during postoperative pain
self-assessment by the patient at home on the information collection book
Measured: At Morning and evening between the 1 and 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Goeffrey Mortuaire, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821169
- Sponsor's protocol ID
- 2013_07
- Other IDs
- 2013-004410-17
- Acronym
- ROPI_POSTOP
- Status last verified
- Sep 2019
- First submitted
- 29 Jun 2016
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34013619
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02821169
- Acronym / sponsor ID
- ROPI_POSTOP / 2013_07
- Conditions
- Pain
- Keywords
- sinus surgery, sphenopalatin ganglion, ropivacaine, local anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline solution 0.9% | Placebo comparator | Drug: saline solution 0.9%injection of saline solution in the sphenopalatine area in both nasal fossa |
| ropivacaine (2mg/ml) | Active comparator | Drug: ropivacaineinjection of ropivacaine in the sphenopalatine area in both nasal fossa |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients requiring endoscopic sinus surgery
- ASA score 1 or 2
- patients with health care insurance
- approved consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaineAlso: NAROPEINEinjection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach | Drug | ropivacaine (2mg/ml) |
| saline solution 0.9%Also: NaCL 0.9% injectableinjection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach | Drug | saline solution 0.9% |
Primary outcome
Visual analog scale
Time frame: at the 2 postoperative hours
Measure the intensity pain, in the group treated with Ropivacaine.
4 secondary outcomes
Analgesics consumption orally
Time frame: during the 7 days post-surgery
Administration of analgesics by parenteral route
Time frame: at the 2 postoperative hours
Visual analog scale for the intensity postoperative pain
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 34013619Morisse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goeffrey Mortuaire, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ropivacaine and saline solution 0.9% in people with Pain, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: at the 2 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.