PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

Not Applicable

Not yet recruiting

• Conditions: Thyroid Cancer
• Interventions: Procedure: Pectoral nerve block

• Registration Number: NCT06101043
• Lead Sponsor: Min Suk Chae

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 available

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Study Start: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-09-28
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS II block group	Pectoral nerve block	-

Primary Outcome Measures

Name	Time	Method
Analgesic efficacy	the day after surgery	Visual analog scale from 0 (minimum) to 10 (maximum)

Secondary Outcome Measures

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