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

University Hospital, Lille

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: saline solution 0.9%; Drug: ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02821169

2013-004410-17 (EudraCT Number)

2013_07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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184 participants in 2 patient groups, including a placebo group

saline solution 0.9%

Placebo Comparator group

Description:

injection of saline solution in the sphenopalatine area in both nasal fossa

Treatment:

Drug: saline solution 0.9%

ropivacaine (2mg/ml)

Active Comparator group

Description:

injection of ropivacaine in the sphenopalatine area in both nasal fossa

Treatment:

Drug: ropivacaine