PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: Pectoral nerve block

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Suk Chae, MD, PhD; Phone Number: 82-2-2258-6150; Email: shscms@gmail.com
• Study Contact Backup: Name: Kwangsoon Kim, MD, PhD; Phone Number: 82-2-2258-6784; Email: noar99@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PECS II block group	Procedure: 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).
No Intervention: No PECS II block group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Min Suk Chae

Study record dates

Study Major Dates

• Study Start (Estimated): January 4, 2024
• Primary Completion (Estimated): September 28, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms
• Other Study ID Numbers: KC22EISI0542

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No