PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

NCT ID: NCT06101043

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2024-09-30

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.

Conditions

Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PECS II block group

Group Type: EXPERIMENTAL

Pectoral nerve block

Intervention Type: 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 The anesthetic spread around the axilla, and the needle was withdrawn to the point in the plane between the pectoralis major and minor muscles.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).

No PECS II block group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pectoral nerve block

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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Min Suk Chae

OTHER

Sponsor Role: lead

Responsible Party

Min Suk Chae

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Min Suk Chae, MD, PhD

Role: CONTACT

shscms@gmail.com

82-2-2258-6150

Kwangsoon Kim, MD, PhD

Role: CONTACT

noar99@naver.com

82-2-2258-6784

Other Identifiers

KC22EISI0542

Identifier Type: -

Identifier Source: org_study_id