## Protocol Section
### Identification Module
**NCT ID:** NCT06426186

**Brief Title:** Effect of Right-stellate Ganglion Block in Preventing on Postoperative Nausea and Vomiting

**Official Title:** Effect of Right-stellate Ganglion Block in Preventing Postoperative Nausea and Vomiting in Gynecological Laparoscopic Patients

#### Organization Study ID Info
**ID:** PONV-Gynecological surgery
#### Organization
**Class:** OTHER
**Full Name:** The Second Affiliated Hospital of Chongqing Medical University
### Status Module
#### Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-08

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Second Affiliated Hospital of Chongqing Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Postoperative nausea and vomiting is one of the common postoperative complications. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk operations such as gynecological laparoscopy is higher. Postoperative nausea and vomiting can lead to perioperative complications and seriously affect the prognosis of patients. Although various preventive and therapeutic measures have been adopted in clinic, the incidence of perioperative nausea and vomiting is still high. Therefore, it is of great clinical significance to explore more effective and feasible methods to prevent the occurrence of PONV. Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this project aims to explore the preventive effect of stellate ganglion block on postoperative nausea and vomiting in gynecological laparoscopic surgery patients, and to explore its possible mechanism.

**Detailed Description:** Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as gynecologic laparoscopy is higher. The pathogenesis of postoperative nausea and vomiting is very complex, including central, peripheral receptors and multiple nerve pathways. When peripheral receptors are stimulated, the signal passes through the afferent nerve to the vomiting center, causing nausea and vomiting. The emetic chemical receptors are rich in many receptors, which can directly feel various toxins, metabolites or drugs in the blood and cerebrospinal fluid, project signals to the nerve center and then spread to the cerebral cortex, causing nausea and vertigo, or transmit signals along the vagus nerve, glossopharyngeal nerve, spinal nerve, etc. to the digestive tract, diaphragm and abdominal wall muscles, resulting in the opening of the sphincter in the upper esophagus and strong contraction of the diaphragm. Abdominal muscles contract, so that the stomach pressure increases, stomach contents through the digestive tract is expelled from the body, vomiting.

There are many factors affecting postoperative nausea and vomiting in gynecological laparoscopic surgery, including patient factors, anesthetic factors and surgical factors. Firstly, gender as an independent risk factor for postoperative nausea and vomiting is widely recognized by researchers, and a large number of studies have confirmed that the incidence of postoperative nausea and vomiting is higher in females, and the possible mechanism is caused by different hormone levels. Secondly, some studies believe that the type of surgery is also a risk factor for postoperative nausea and vomiting, but there is some controversy. In general, laparoscopic surgery patients have a higher incidence of postoperative nausea and vomiting. Finally, the mode of anesthesia and anesthesia-related drugs are also one of the risk factors affecting PONV. Compared with other anesthesia methods, the incidence of PONV was increased under general anesthesia, and the combination of intravenous anesthesia and intraoperative opioid application also increased the incidence of postoperative nausea and vomiting.

Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this study will explore the preventive effect of stellate ganglion block on postoperative nausea and vomiting in gynecological laparoscopic patients, and hope to explore its possible mechanism, so as to provide more effective and feasible methods for clinical prevention of postoperative nausea and vomiting and improve patients' medical comfort and satisfaction.

### Conditions Module

**Conditions:**

- Postoperative Nausea and Vomiting

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Right-stellate ganglion block was given 30 minutes before anesthesia induction

**Intervention Names:**

- Procedure: Right-stellate ganglion block

**Label:** Right-stellate ganglion block

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No treatment was given 30 minutes before anesthesia induction

**Label:** Blank control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Right-stellate ganglion block

**Description:** The experimental group was given right stellate ganglion block 30 minutes before anesthesia

**Name:** Right-stellate ganglion block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Postoperative nausea and vomiting is evaluated by follow-up

**Measure:** The incidence of postoperative nausea and vomiting

**Time Frame:** From end of surgery to 24 hours after surgery

#### Secondary Outcomes

**Description:** Postoperative nausea and vomiting is evaluated by investigator's follow-up

**Measure:** Incidence of nausea and vomiting during preemptive analgesia

**Time Frame:** From 0-10 min after preemptive analgesia

**Description:** ntensity of nausea and vomiting (the scale is Rhodes index of nausea and vomiting)is evaluated by numerical rating scale (0-10), which higher socre represents more severe the nausea and vomiting

**Measure:** Intensity of nausea and vomiting during preemptive analgesia

**Time Frame:** From 0-10 min after preemptive analgesia

**Description:** Intensity of nausea and vomiting is evaluated by numeric rating scale (0-10), which higher socre represents more uncomfortable

**Measure:** Intensity of nausea and vomiting during hospitalization

**Time Frame:** From end of surgery to 24 hours after surgery

**Description:** Mean arterial pressure in mmHg,heart rate in bpm,oxygen saturation（%）

**Measure:** Hemodynamic parameters

**Time Frame:** Before stellate ganglion block and From 0-30 min after Satellite Ganglion Blocks

**Description:** Postoperative pain intensity is assessed by numeric rating scale (0-10), which higher socre represents more uncomfortable

**Measure:** Postoperative pain intensity

**Time Frame:** From end of surgery to 24 hours after surgery

**Description:** Gastrointestinal function is is assessed by the evacuation time

**Measure:** Recovery of gastrointestinal function

**Time Frame:** From end of surgery to 24 hours after surgery

**Description:** Sleep quality is is assessed by numeric rating scale (0-10), which higher socre represents better sleep quality

**Measure:** Sleep quality

**Time Frame:** From end of surgery to 1 day after surgery

**Description:** Satisfaction score and postoperative analgesia satisfaction score is assessed by numeric rating scale (0-10), which higher socre represents more comfortable

**Measure:** Satisfaction score and postoperative analgesia satisfaction score

**Time Frame:** From end of surgery to hospital discharge with about 5 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age ≥18 years and ≤ 70 years
2. American Society of Anesthesiologists(ASA) physical status classification I-Ill.
3. Voluntary participation and ability to understand and sign the informed consent form
4. Patients undergoing gynecological laparoscopic surgery elective general anesthesia

Exclusion Criteria:

1. Patients with obesity(BMI\>30kg/m2)
2. Contraindicated to stellate ganglion block
3. Patients who cannot cooperate with the study for any reason,or whom the investigator deems unsuitable for inclusion in this trial.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 302069@hospital.cqmu.edu.cn

**Name:** ling Dan, BD

**Phone:** 13983072922

**Phone Ext:** 86

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chongqing

**Contacts:**

***Contact 1:***

- **Email:** 302069@hospital.cqmu.edu

- **Name:** ling Dan, BD

- **Phone:** 86 13983072922

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Affiliated Hospital of Chongqing Medical University

**State:** Chongqing

**Status:** RECRUITING

**Zip:** 400000

#### Overall Officials

**Official 1:**

**Affiliation:** The Second Affilated Hospital of Chongqing Medical University

**Name:** ling Dan, BD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** all IPD that underlie results in a publication

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M12273

- Name: Nausea

- Relevance: HIGH

- As Found: Nausea

- ID: M17582

- Name: Vomiting

- Relevance: HIGH

- As Found: Vomiting

- ID: M22074

- Name: Postoperative Nausea and Vomiting

- Relevance: HIGH

- As Found: Postoperative Nausea and Vomiting

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009325

- Term: Nausea

- ID: D000014839

- Term: Vomiting

- ID: D000020250

- Term: Postoperative Nausea and Vomiting

### 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: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
