NCT06426186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

July 29, 2024

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

April 14, 2024

Last Update Submit

July 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative nausea and vomiting

    Postoperative nausea and vomiting is evaluated by follow-up

    From end of surgery to 24 hours after surgery

Secondary Outcomes (8)

  • Incidence of nausea and vomiting during preemptive analgesia

    From 0-10 minutes after preemptive analgesia

  • Intensity of nausea and vomiting during preemptive analgesia

    From 0-10 minutes after preemptive analgesia

  • Intensity of nausea and vomiting during hospitalization

    From end of surgery to 24 hours after surgery

  • Hemodynamic parameters

    When patients enter the operation room (T0),Immediately before intubation(T1,about 30minutes after SGB),Immediately after intubation(T2,about 35minutes after SGB), trendelenburg position after completion (T3),At the end of the operation(T4)

  • Postoperative pain intensity

    From end of surgery to 24 hours after surgery

  • +3 more secondary outcomes

Study Arms (2)

Right-stellate ganglion block

EXPERIMENTAL

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

Procedure: Right-stellate ganglion block

Blank control group

NO INTERVENTION

No treatment was given 30 minutes before anesthesia induction

Interventions

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

Right-stellate ganglion block

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with obesity(BMI\>30kg/m2)
  • Contraindicated to stellate ganglion block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (1)

  • Liu Y, Piao G, Chen J, Duan G, Dan L, Chen G, Zhang Y. Effect of Right Stellate Ganglion Block on Preventing Postoperative Nausea and Vomiting in Gynecological Laparoscopic Patients: A Randomized Controlled Trial. Adv Ther. 2025 Mar;42(3):1537-1549. doi: 10.1007/s12325-025-03109-7. Epub 2025 Feb 10.

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • ling Dan, BD

    The Second Affilated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2024

First Posted

May 23, 2024

Study Start

June 9, 2023

Primary Completion

June 27, 2024

Study Completion

June 27, 2024

Last Updated

July 29, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Locations