Stellate Ganglion BlockNCT06371131
Effect of Stellate Ganglion Block on Postoperative Nausea and Vomiting
A study testing Right -stellate ganglion block in people with Stellate Ganglion Block and Thyroid Surgery, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stellate Ganglion Block, Thyroid Surgery, Postoperative Nausea and Vomiting
- What is being tested?
- Right -stellate ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving thyroid surgery under general anesthesia
- Age ≥18 years and ≤ 70 years
- American Society of Anesthesiologists(ASA) physical status classification I-III.
- Voluntary participation and ability to understand and sign the informed consent form.
Who cannot join
- Patients with obesity(BMI>30 kg/m2)
- contraindicated to stellate ganglion block
- Patients who cannot cooperate with the study for any reason, or whom the investigator deems unsuitable for inclusion in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
ling Dan, BD, 86 13983072922, 302069@hospital.cqmu.edu.cn
About this study
Official title: Effect of Right⁃Stellate Ganglion Block on Postoperative Nausea and Vomiting in Patients Undergoing Thyroid Surgery
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 thyroid surgery is even up to 70-80%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action.
Read the 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 thyroid surgery is even up to 70-80%. 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.
Thyroid, as the endocrine organ of human body, mainly secretes thyroid hormone and participates in human metabolism. With the progress of modern medical technology, although thyroid postoperative complications have decreased, due to the limited operating space of thyroid surgery, in order to fully exposed the surgical field of vision and facilitate the operation of surgeons, patients often take the cervical hyperextension position, that is, patients take the supine position with high shoulder pads. Tilt your head back so that your lower jaw, trachea, and sternum are at the same level, allowing the thyroid gland to protrate forward as much as possible. Although this position is easy for surgeons to operate, due to the complex anatomical structure around the thyroid gland, adjacent to important blood vessels and nerves, this position often causes thyroid surgical position syndrome in patients, that is, nausea and vomiting, dizziness, headache, tinnitus, neck radiation pain and other symptoms, which not only increases patients' pain, but also seriously reduces patients' medical experience.
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 thyroid nausea and vomiting, 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.
- Being tested
- Right -stellate ganglion block
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right -stellate ganglion blockProcedure or surgery
The experimental group was given right stellate ganglion block 30 minutes before anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Right stellate ganglion block | Experimental | Right -stellate ganglion block was given 30minutes before anesthesia induction. Receives: Procedure: Right -stellate ganglion block |
| Blank control group | No intervention | No treatment was given 30 minutes before anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative nausea and vomiting
Postoperative nausea and vomiting is evaluated by follow-up
Measured: From end of surgery to 24 hours after surgery
Secondary outcomes (8)
Incidence of Postoperative nausea and vomiting during preemptive analgesia
Postoperative nausea and vomiting is evaluated by investigator's follow-up
Measured: From 0-10 min after preemptive analgesia
Intensity of nausea and vomiting during preemptive analgesia
Intensity of nausea and vomiting is evaluated by numeric rating scale (0-10), which higher socre represents more uncomfortable
Measured: From 0-10 min after preemptive analgesia
Intensity of nausea and vomiting during hospitalization
Intensity of nausea and vomiting is evaluated by numeric rating scale (0-10), which higher socre represents more uncomfortable
Measured: From end of surgery to 24 hours after surgery
Hemodynamic parameters after preemptive analgesia
Systolic blood pressure,dastolic blood pressure,mean arterial pressure,heart rate,oxygen saturation,Patient state index
Measured: From 0-10 min after preemptive analgesia
Postoperative pain intensity
Postoperative pain intensity is assessed by numeric rating scale (0-10), which higher socre represents more uncomfortable
Measured: From end of surgery to 24 hours after surgery
Recovery of gastrointestinal function
Gastrointestinal function is is assessed by the evacuation time
Measured: From end of surgery to 24 hours after surgery
Sleep quality
Sleep quality is is assessed by numeric rating scale (0-10), which higher socre represents better sleep quality
Measured: From end of surgery to 1 day after surgery
Satisfaction score and postoperative analgesia satisfaction score
Satisfaction score and postoperative analgesia satisfaction score is assessed by numeric rating scale (0-10), which higher socre represents more uncomfortable
Measured: From end of surgery to hospital discharge with about 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start17 Apr 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: right stellate ganglion block 30 minutes before anesthesia induction.Control group: No treatment was given 30minutes before anesthesia induction.Data was recorded at the corresponding time points.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ling Dan, BD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371131
- Sponsor's protocol ID
- PONV of Thyroid Surgery
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Right⁃Stellate Ganglion Block on Postoperative Nausea and Vomiting in Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT06371131
- Acronym / sponsor ID
- PONV of Thyroid Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 thyroid surgery is even up to 70-80%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action.
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 thyroid surgery is even up to 70-80%. 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.
Thyroid, as the endocrine organ of human body, mainly secretes thyroid hormone and participates in human metabolism. With the progress of modern medical technology, although thyroid postoperative complications have decreased, due to the limited operating space of thyroid surgery, in order to fully exposed the surgical field of vision and facilitate the operation of surgeons, patients often take the cervical hyperextension position, that is, patients take the supine position with high shoulder pads. Tilt your head back so that your lower jaw, trachea, and sternum are at the same level, allowing the thyroid gland to protrate forward as much as possible. Although this position is easy for surgeons to operate, due to the complex anatomical structure around the thyroid gland, adjacent to important blood vessels and nerves, this position often causes thyroid surgical position syndrome in patients, that is, nausea and vomiting, dizziness, headache, tinnitus, neck radiation pain and other symptoms, which not only increases patients' pain, but also seriously reduces patients' medical experience.
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 thyroid nausea and vomiting, 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: right stellate ganglion block 30 minutes before anesthesia induction.Control group: No treatment was given 30minutes before anesthesia induction.Data was recorded at the corresponding time points.
| Arm | Type | Receives |
|---|---|---|
| Right stellate ganglion block | Experimental | Procedure: Right -stellate ganglion blockRight -stellate ganglion block was given 30minutes before anesthesia induction. |
| Blank control group | No intervention | –No treatment was given 30 minutes before anesthesia induction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving thyroid surgery under general anesthesia
- Age ≥18 years and ≤ 70 years
- American Society of Anesthesiologists(ASA) physical status classification I-III.
- Voluntary participation and ability to understand and sign the informed consent form.
Key exclusion criteria (3 listed)
- Patients with obesity(BMI>30 kg/m2)
- contraindicated to stellate ganglion block
- Patients who cannot cooperate with the study for any reason, or whom the investigator deems unsuitable for inclusion in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right -stellate ganglion blockThe experimental group was given right stellate ganglion block 30 minutes before anesthesia induction | Procedure or surgery | Right stellate ganglion block |
Primary outcome
Incidence of Postoperative nausea and vomiting
Time frame: From end of surgery to 24 hours after surgery
Postoperative nausea and vomiting is evaluated by follow-up
8 secondary outcomes
Incidence of Postoperative nausea and vomiting during preemptive analgesia
Time frame: From 0-10 min after preemptive analgesia
Intensity of nausea and vomiting during preemptive analgesia
Time frame: From 0-10 min after preemptive analgesia
Intensity of nausea and vomiting during hospitalization
Time frame: From end of surgery to 24 hours after surgery
Hemodynamic parameters after preemptive analgesia
Time frame: From 0-10 min after preemptive analgesia
Postoperative pain intensity
Time frame: From end of surgery to 24 hours after surgery
Recovery of gastrointestinal function
Time frame: From end of surgery to 24 hours after surgery
Sleep quality
Time frame: From end of surgery to 1 day after surgery
Satisfaction score and postoperative analgesia satisfaction score
Time frame: From end of surgery to hospital discharge with about 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
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Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ling Dan, BD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right -stellate ganglion block in people with Stellate Ganglion Block and Thyroid Surgery, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ling Dan, BD (13983072922 ext. 86, 302069@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative nausea and vomiting (time frame: From end of surgery to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.