Clinical trial NCT06695624: Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block on Postoperative Pain After Septoplasty
Official title: Investigation of the Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block in Management of Postoperative Pain After Septoplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: sphenopalatine ganglion block
septoplasty
postoperative pain
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: visual analogue scale
timeFrame: 24 hours
measure: total amount of tramadol consumption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Umraniye Education and Research Hospital Collaborators:
name: şenay göksu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Qudah M. Endoscopic sphenopalatine ganglion blockade efficacy in pain control after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):334-8. doi: 10.1002/alr.21644. Epub 2015 Sep 15.
citation: Ekici NY, Alagoz S. The effectiveness of endoscopic sphenopalatine ganglion block in management of postoperative pain after septal surgery. Int Forum Allergy Rhinol. 2019 Dec;9(12):1521-1525. doi: 10.1002/alr.22411. Epub 2019 Sep 5.