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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: saline solution 0.9%; Drug: ropivacaine

• Registration Number: NCT02821169
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-01
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
saline solution 0.9%	saline solution 0.9%	injection of saline solution in the sphenopalatine area in both nasal fossa
ropivacaine (2mg/ml)	ropivacaine	injection of ropivacaine in the sphenopalatine area in both nasal fossa

Primary Outcome Measures

Name	Time	Method
Visual analog scale	at the 2 postoperative hours	Measure the intensity pain, in the group treated with Ropivacaine.

Secondary Outcome Measures

Name	Time	Method
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 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
Visual analog scale for the intensity postoperative pain	at the 4 and at the 6 postoperative hours	patient-controlled administration

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France