## Protocol Section
### Identification Module
**NCT ID:** NCT04168879

**Brief Title:** Sphenopalatine Ganglion Block for Nasal Surery

**Official Title:** Efficacy of Suprazygomatic Approach of Sphenopalatine Ganglion Block for Nasal Surery

#### Organization Study ID Info
**ID:** ACCA
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2023-12-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-13

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-10

**Type:** ACTUAL

#### Start Date
**Date:** 2021-11-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2019-11-19
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-16
**Study First Submit QC Date:** 2019-11-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** saeid metwaly abouelyazid elsawy

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Rasha Hamed

**Investigator Title:** lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge.

### Conditions Module

**Conditions:**

- Postoperative Delirium

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 108

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution

**Label:** bupivacaine group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: normal saline

**Label:** saline group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- bupivacaine group

**Description:** 1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used to block the sphenopalatine ganglion by ultrasound guided suprazygomatic approach

**Name:** Bupivacaine 0.5% Preservative-Free Injectable Solution

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- saline group

**Description:** 1.5 ml of normal saline is delivered to the sphenopalatine ganglion by ultrasound guided suprazygomatic approach

**Name:** normal saline

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** suction and weight of surgical gauze used was measured and calculated

**Measure:** intraoperative bleeding

**Time Frame:** 2 hours

#### Primary Outcomes

**Description:** ramsy hunt sedation agitation score used during emergence from anesthesia

**Measure:** Postoperative emergence agitation

**Time Frame:** 2 hour

#### Secondary Outcomes

**Description:** total amount of opioid analgesia in first 24 hours postoperative

**Measure:** postoperative opioid consumption

**Time Frame:** 24 hour

**Description:** Boezaart score was be used

**Measure:** surgical field quality

**Time Frame:** 2 hours

**Description:** mean anesthesia MAC intraoperative

**Measure:** consumed inhalational anesthesia

**Time Frame:** 2 hours

**Description:** using VAS ; scale from 0 to 10 . where 0 is no pain and 10 is worst pain

**Measure:** postoperative pain

**Time Frame:** 2 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patient written consent
* elective surgery
* age 18 - 55 year old

Exclusion Criteria:

* patient refusal
* emergency surgery

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Asyut

**Country:** Egypt

**Facility:** Faculty of Medicine

**Zip:** 71111

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003693

- Term: Delirium

- ID: D000003221

- Term: Confusion

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M6894

- Name: Delirium

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M772

- Name: Emergence Delirium

- Relevance: HIGH

- As Found: Postoperative Delirium

- ID: M6446

- Name: Confusion

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000071257

- Term: Emergence Delirium

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

- Version Holder: 2024-05-24
