PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06101043
• Other study ID #: KC22EISI0542
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Seoul St. Mary's Hospital
• Contact: Min Suk Chae, MD, PhD
• Phone: 82-2-2258-6150
• Email: shscms[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: September 30, 2024
• Est. primary completion date: September 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Min Suk Chae

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic efficacy	Visual analog scale from 0 (minimum) to 10 (maximum)	the day after surgery
Secondary	Quality of postoperative surgery course	The Korean version of QoR-15 (QoR-15K questionnaire) from 0 (minimum) to 150 (maximum)	the day after surgery