Pain
Conditions
Keywords
sinus surgery, sphenopalatin ganglion, ropivacaine, local anesthesia
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.
Interventions
DRUGropivacaine
injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach
injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale | at the 2 postoperative hours | Measure the intensity pain, in the group treated with Ropivacaine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesics consumption orally | during the 7 days post-surgery | patient-controlled administration |
| Administration of analgesics by parenteral route | at the 2 postoperative hours | patient-controlled administration |
| Visual analog scale for the intensity postoperative pain | at the 4 and at the 6 postoperative hours | patient-controlled administration |
| Visual analog scale for the during postoperative pain | At Morning and evening between the 1 and 7 days post surgery | self-assessment by the patient at home on the information collection book |
Countries
France
Outcome results
None listed