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

NCT06695624 | Not Yet Recruiting

• 1 other identifier: SPGB-FULYA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

sphenopalatine ganglion block; septoplasty; postoperative pain

Outcome Measures

Primary Outcomes (2)

• visual analogue scale

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

  24 hours

• total amount of tramadol consumption

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

  24 hours

Study Arms (2)

group with sphenopalatine ganglion block

ACTIVE COMPARATOR

Sphenopalatine ganglion block will be performed for participants undergoing septoplasty.

Procedure: Sphenopalatine Ganglion Block

group without sphenopalatine ganglion block

NO INTERVENTION

Sphenopalatine ganglion block will not be performed for participants undergoing septoplasty

Interventions

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.

group with sphenopalatine ganglion block

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Related Publications (2)

• 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.

  PMID: 26370724 BACKGROUND

• 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.

  PMID: 31487422 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• şenay göksu, MD

  Umraniye Education and Research Hospital Collaborators:

  PRINCIPAL INVESTIGATOR

Central Study Contacts

şenay göksu, MD

CONTACT

905337144852; senaytomruk@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share