PECS II Block and Single Port Robot-assisted Transaxillar... | NCT06101043

Studies
PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

NCT06101043

Sponsor

Min Suk Chae

Status

Unknown status

Last Update Posted

Jan 5, 2024Actual

Enrollment

76Estimated

Phase

Not Applicable

Conditions

Thyroid Cancer

Interventions

Pectoral nerve block

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2024Estimated

Primary Completion Date

Sep 28, 2024Estimated

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Oct 19, 2023

First Submission Date that Met QC Criteria

Oct 19, 2023

First Posted Date

Oct 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2024

Last Update Posted Date

Jan 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PECS II block group	Experimental		Procedure: Pectoral nerve block
No PECS II block group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pectoral nerve block	Procedure	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analgesic efficacy	Visual analog scale from 0 (minimum) to 10 (maximum)	the day after surgery

Secondary Outcomes

Measure	Description	Time Frame
Quality of postoperative surgery course	The Korean version of QoR-15 (QoR-15K questionnaire) from 0 (minimum) to 150 (maximum)	the day after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients requiring lateral cervical lymph node dissection
pregnant women
Uncontrolled diabetes
Chronic kidney failure
Patients with previous neck surgery
Patients with Graves' disease
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Suk Chae, MD, PhD	Contact	82-2-2258-6150		shscms@gmail.com
Kwangsoon Kim, MD, PhD	Contact	82-2-2258-6784		noar99@naver.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided