PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

Sponsor

Min Suk Chae (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06101043

Collaborator

(none)

Enrollment

Arms

10.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer	Procedure: Pectoral nerve block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 2, 2023

Anticipated Primary Completion Date :

Sep 28, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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 The anesthetic spread around the axilla, and the needle was withdrawn to the point in the plane between the pectoralis major and minor muscles.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

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

Outcome Measures

Primary Outcome Measures

Analgesic efficacy [the day after surgery]
Visual analog scale from 0 (minimum) to 10 (maximum)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Min Suk Chae

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Min Suk Chae, Assistant professor, Seoul St. Mary's Hospital

ClinicalTrials.gov Identifier:

NCT06101043

Other Study ID Numbers:

KC22EISI0542

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 27, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thyroid Neoplasms

Study Results

No Results Posted as of Oct 27, 2023