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

Pain Clinical Trial

— ROPI_POSTOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821169
• Other study ID #: 2013_07
• Secondary ID: 2013-004410-17
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: June 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Pain
• Pain, Postoperative

Intervention

Drug:
• ropivacaine
injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach
• saline solution 0.9%
injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	Measure the intensity pain, in the group treated with Ropivacaine.	at the 2 postoperative hours
Secondary	Analgesics consumption orally	patient-controlled administration	during the 7 days post-surgery
Secondary	Administration of analgesics by parenteral route	patient-controlled administration	at the 2 postoperative hours
Secondary	Visual analog scale for the intensity postoperative pain	patient-controlled administration	at the 4 and at the 6 postoperative hours
Secondary	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