Thyroid CancerNCT06101043
PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy
A study testing Pectoral nerve block in people with Thyroid Cancer, run by Min Suk Chae.
Trial summary
The da Vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Pectoral nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2024to 30 Sep 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy)
- Patients with cancer stages T1 or T2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination
- Patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination
- Patients with a BMI greater than or equal to 18.5 and less than 30.0.
Who cannot join
- Patients requiring lateral cervical lymph node dissection
- pregnant women
- Uncontrolled diabetes
- Chronic kidney failure
- Patients with previous neck surgery
- Patients with Graves' disease
Show all 12Show fewer
- People with chronic alcoholism
- Patients with vocal cord paralysis before surgery
- Severe obese patients with a body mass index >35 kg/m2
- Patients participating in another clinical trial within 30 days
- Patients who expect that it will be difficult for medical staff to fill out the questionnaire on their own
- Patients whose medical staff determines that participation in the study is difficult due to other underlying diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the PECS II Block With Postoperative Pain in Patients Undergoing Single Port Robot-assisted Transaxillary Thyroidectomy: Double-blinded Randomized Controlled Trial
The da Vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). Although the system has many advantages, skin incision, wide flap dissection, and pneumatic/mechanical retraction remain essential, but cause postoperative pain and slower recovery. Previous studies found that pectoralis fascial blocks were easy to establish; local anesthetics are injected between two adjacent myofascial layers under ultrasound guidance, providing the surgeon with a clear image. Analgesic efficacy has been validated during robotic thyroidectomy in our institution. The pain outcomes were comparable between the groups, but there were fewer complications in the PECS II group. The investigators investigated whether this block can reduce postoperative pain during wide flap dissection for single-port robot-assisted transaxillary thyroidectomy.
- Conditions
- Thyroid Cancer
- Being tested
- Pectoral nerve block
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral nerve blockProcedure or surgery
An ultrasound probe was placed obliquely over the second and third ribs below the lateral one-third of the clavicle. After identification of the anatomical structures, the needle was advanced along a superior-medial-to-inferior-lateral passage to the tissue plane between the pectoralis minor and serratus anterior muscles, and 20 mL ropivacaine (0.375% w/v) was injected at the level of the third rib. The anesthetic spread around the axilla, and the needle was withdrawn to the point in the plane between the pectoralis major and minor muscles. A second injection of 20 mL ropivacaine (0.375% w/v) was then delivered (PECS II).
| Study group | Role | What they receive |
|---|---|---|
| PECS II block group | Experimental | Not described Receives: Procedure: Pectoral nerve block |
| No PECS II block group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy
Visual analog scale from 0 (minimum) to 10 (maximum)
Measured: the day after surgery
Secondary outcomes (1)
Quality of postoperative surgery course
The Korean version of QoR-15 (QoR-15K questionnaire) from 0 (minimum) to 150 (maximum)
Measured: the day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start4 Jan 2024 (estimated)
- Primary completion28 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Suk Chae
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Suk Chae, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101043
- Sponsor's protocol ID
- KC22EISI0542
- Status last verified
- Jan 2024
- First submitted
- 19 Oct 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the PECS II Block With Postoperative Pain in Patients Undergoing Single Port Robot-assisted Transaxillary Thyroidectomy: Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06101043
- Acronym / sponsor ID
- KC22EISI0542
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Min Suk ChaeUniversity, hospital or other
- Study start
- 4 Jan 2024 (estimated)
- Primary completion
- 28 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
The da Vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). Although the system has many advantages, skin incision, wide flap dissection, and pneumatic/mechanical retraction remain essential, but cause postoperative pain and slower recovery. Previous studies found that pectoralis fascial blocks were easy to establish; local anesthetics are injected between two adjacent myofascial layers under ultrasound guidance, providing the surgeon with a clear image. Analgesic efficacy has been validated during robotic thyroidectomy in our institution. The pain outcomes were comparable between the groups, but there were fewer complications in the PECS II group. The investigators investigated whether this block can reduce postoperative pain during wide flap dissection for single-port robot-assisted transaxillary thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS II block group | Experimental | Procedure: Pectoral nerve block |
| No PECS II block group | No intervention | – |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy)
- Patients with cancer stages T1 or T2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination
- Patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination
- Patients with a BMI greater than or equal to 18.5 and less than 30.0.
Key exclusion criteria (12 listed)
- Patients requiring lateral cervical lymph node dissection
- pregnant women
- Uncontrolled diabetes
- Chronic kidney failure
- Patients with previous neck surgery
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 |
|---|---|---|
| Pectoral nerve blockAn ultrasound probe was placed obliquely over the second and third ribs below the lateral one-third of the clavicle. After identification of the anatomical structures, the needle was advanced along a superior-medial-to-inferior-lateral passage to the tissue plane between the pectoralis minor and serratus anterior muscles, and 20 mL ropivacaine (0.375% w/v) was injected at the level of the third rib. The anesthetic spread around the axilla, and the needle was withdrawn to the point in the plane between the pectoralis major and minor muscles. A second injection of 20 mL ropivacaine (0.375% w/v) was then delivered (PECS II). | Procedure or surgery | PECS II block group |
Primary outcome
Analgesic efficacy
Time frame: the day after surgery
Visual analog scale from 0 (minimum) to 10 (maximum)
1 secondary outcome
Quality of postoperative surgery course
Time frame: the day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoral nerve block in people with Thyroid Cancer, run by Min Suk Chae.
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 12 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Min Suk Chae, MD, PhD (82-2-2258-6150, shscms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic efficacy (time frame: the day 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 5 Jan 2024.