Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.
Overview
- Phase
- Phase 3
- Intervention
- saline solution 0.9%
- Conditions
- Pain
- Sponsor
- University Hospital, Lille
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Visual analog scale
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
saline solution 0.9%
injection of saline solution in the sphenopalatine area in both nasal fossa
Intervention: saline solution 0.9%
ropivacaine (2mg/ml)
injection of ropivacaine in the sphenopalatine area in both nasal fossa
Intervention: ropivacaine
Outcomes
Primary Outcomes
Visual analog scale
Time Frame: at the 2 postoperative hours
Measure the intensity pain, in the group treated with Ropivacaine.
Secondary Outcomes
- 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 during postoperative pain(At Morning and evening between the 1 and 7 days post surgery)
- Visual analog scale for the intensity postoperative pain(at the 4 and at the 6 postoperative hours)