## Protocol Section
### Identification Module
**NCT ID:** NCT06417723

**Brief Title:** Effect of Maxillary Nerve Block for Septoplasty

**Official Title:** Effect of Maxillary Nerve Block for Septoplasty

#### Organization Study ID Info
**ID:** ADYU-ANS-NY-04
#### Organization
**Class:** OTHER
**Full Name:** Adiyaman University Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Adiyaman University Research Hospital

#### Responsible Party

**Investigator Affiliation:** Adiyaman University Research Hospital

**Investigator Full Name:** Nezir Yılmaz

**Investigator Title:** Associate Professor,MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study was to determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations.

**Detailed Description:** Patients who were planned to be operated for septoplasty at Adıyaman University Training and Research Hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study.

The patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour were recorded and these values were compared in both groups.

Thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations.

### Conditions Module

**Conditions:**

- Post Operative Pain

**Keywords:**

- postoperative pain

- maxillary nerve block

- septoplasty

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** two groups designed from septoplasty patintes for study.

1. only general anesthesia
2. General anesthesia + maxillary nerve block

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** for patients - closed envelope system for investigator - Maxillary nerve block performer will not participate pain and results assesment

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Bilateral maxillary nerve block was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded .

**Intervention Names:**

- Procedure: Maxillary nerve block

**Label:** Block group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No intevention was planned for this group. Only genaeral anesthesia applications will use for surgery. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded .

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Block group

**Description:** It is aimed to reach the maxillary nerve trace with a peripheral nerve block needle using the suprazigomatic approach and to create a temporary block in the maxillary nerve with local anaesthetic injection.

**Name:** Maxillary nerve block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** postoperative pain scores will be assesed in 24 hours after surgery

**Measure:** The visual analog pain score

**Time Frame:** three months

#### Secondary Outcomes

**Description:** a tool that asses recovery quality of paitent after surgery with 15 question will be used at 24th hour after surgery

**Measure:** Quality of recovery (QoR -15)

**Time Frame:** three months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I-II , Septoplasty patints

Exclusion Criteria:

* ASA III-IV
* Deny to participte in study

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yilmaznezirr@gmail.com

**Name:** Nezir Yılmaz

**Phone:** 05068939496

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Adıyaman

**Country:** Turkey

**Facility:** Adıyaman Training and Research Hospital

**Zip:** 02200

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
