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NCT Number: NCT06695624

Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block on Postoperative Pain After Septoplasty

The aim of this clinical study will investigate the efficacy of sphenopalatine ganglion block in the treatment of postoperative pain.it will also be learnt whether it reduces the consumption of analgesics in postoperative pain.The main questions it aims to answer are:

Will the participants' need for painkillers decrease after the operation? Can sphenopalatine ganglion block be used for postoperative pain after septoplasty? The researchers will compare 2 groups with and without sphenopalatine ganglion block to see the effectiveness of sphenopalatine ganglion block.

Participants will:

Read the information Participants have been given about the sphenopalatine ganglion block.

In case of any side effects, please contact participant's doctor.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This randomised controlled study will be conducted in Umraniye Training and Research Hospital operating room between November 2024 and January 2025 after obtaining ethics committee and patient consent. Each patient will be informed about the procedures to be performed during anaesthesia and surgery and signed informed consent will be obtained before the procedure. Patients will undergo septoplasty by the same otolaryngology team.

A total of 50 participants (25 envelopes each with Group 1 and Group 2 written inside) will be kept closed for the patients participating in the study. Upon the patient's fulfilment of the conditions suitable for the study, it will be randomly determined which group he/she will be included in. Thanks to this randomisation, conscious or unconscious manipulations in the selection of patients to the study group will be prevented.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants who will undergo septoplasty
  • 18 to 50 years old
  • ASA score 1 or 2

Exclusion criteria

  • Under 18 or over 50 years of age
  • ASA score III and above patient group
  • The patient is allergic to any of the drugs used
  • The patient has a contraindication to any of the drugs used
  • Use of anticoagulant medication
  • Failure of the patient to give consent
  • Being pregnant
  • Those with GCS retardation such as dementia, mental retardation
  • Those with diagnosed headache

Treatment and study plan

Sphenopalatine Ganglion Block

Procedure

Sphenopalatine ganglion block group 4cc (80mg) 2% lidocaine + 1cc (4mg) dexamethasone in total 5cc volume will be prepared under sterile conditions before the procedure, 2.5 cc will be given to both nostrils. Sphenopalatine ganglion block will be applied by transnasal endoscopic method.

Primary outcomes

  1. visual analogue scale

    Time frame: 24 hours

    Zero is equivalent to no pain and 10 indicates the worst possible pain.

  2. total amount of tramadol consumption

    Time frame: 24 hours

    Total tramadol consumption will be recorded in the postoperative period by fitting participants with a patient-controlled analgesia device.

Study contacts

Contact information is provided by the study sponsor or research team.

şenay göksu, MD

CONTACT

[email protected]

905337144852

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Official study title

Investigation of the Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block in Management of Postoperative Pain After Septoplasty

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

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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