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Completed

NCT Number: NCT02821169

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU, Hôpital Claude Huriez

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach

Other names: NAROPEINE

Saline solution 0.9%

Drug

injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach

Other names: NaCL 0.9% injectable

Primary outcomes

  1. Visual analog scale

    Time frame: at the 2 postoperative hours

    Measure the intensity pain, in the group treated with Ropivacaine.

Secondary outcomes

  1. Analgesics consumption orally

    Time frame: during the 7 days post-surgery

    patient-controlled administration

  2. Administration of analgesics by parenteral route

    Time frame: at the 2 postoperative hours

    patient-controlled administration

  3. Visual analog scale for the intensity postoperative pain

    Time frame: at the 4 and at the 6 postoperative hours

    patient-controlled administration

  4. Visual analog scale for the during postoperative pain

    Time frame: At Morning and evening between the 1 and 7 days post surgery

    self-assessment by the patient at home on the information collection book

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ROPI_POSTOP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2016
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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