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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004410-17 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saline solution 0.9% | Placebo Comparator | injection of saline solution in the sphenopalatine area in both nasal fossa |
|
| ropivacaine (2mg/ml) | Active Comparator | injection of ropivacaine in the sphenopalatine area in both nasal fossa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine | Drug | injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale | Measure the intensity pain, in the group treated with Ropivacaine. | at the 2 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesics consumption orally | patient-controlled administration | during the 7 days post-surgery |
| Administration of analgesics by parenteral route | patient-controlled administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goeffrey Mortuaire, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, Hôpital Claude Huriez | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34013619 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| saline solution 0.9% | Drug | injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach |
|
|
| at the 2 postoperative hours |
| Visual analog scale for the intensity postoperative pain | patient-controlled administration | 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 | At Morning and evening between the 1 and 7 days post surgery |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |