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

NCT ID: NCT06695624

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-01-31

Brief Summary

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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:

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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group with sphenopalatine ganglion block

Sphenopalatine ganglion block will be performed for participants undergoing septoplasty.

Group Type ACTIVE_COMPARATOR

Sphenopalatine Ganglion Block

Intervention Type 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.

group without sphenopalatine ganglion block

Sphenopalatine ganglion block will not be performed for participants undergoing septoplasty

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sphenopalatine Ganglion Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Senay Goksu

specialist doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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şenay göksu, MD

Role: PRINCIPAL_INVESTIGATOR

Umraniye Education and Research Hospital Collaborators:

Central Contacts

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şenay göksu, MD

Role: CONTACT

905337144852

References

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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.

Reference Type BACKGROUND
PMID: 26370724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31487422 (View on PubMed)

Other Identifiers

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SPGB-FULYA

Identifier Type: -

Identifier Source: org_study_id

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