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

Study Overview
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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.

Official Title
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Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.

Conditions
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Pain

Intervention / Treatment
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* Drug: ropivacaine
* Drug: saline solution 0.9%


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline solution 0.9%<br>injection of saline solution in the sphenopalatine area in both nasal fossa | Drug: saline solution 0.9%<br>* injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach<br>* Other names: NaCL 0.9% injectable;|
| Active Comparator: ropivacaine (2mg/ml)<br>injection of ropivacaine in the sphenopalatine area in both nasal fossa | Drug: ropivacaine<br>* injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach<br>* Other names: NAROPEINE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | Measure the intensity pain, in the group treated with Ropivacaine. | at the 2 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthesia, sinus surgery, sphenopalatin ganglion, ropivacaine