The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction

Not Applicable

Completed

• Conditions: Breast Neoplasm
• Interventions: Procedure: pectoral nerve block

• Registration Number: NCT04440995
• Lead Sponsor: Yonsei University

Brief Summary

Pectoral nerve blocks (PECS blok) are used in postoperative analgesia after breast surgery in nowadays. Many studies shows that pectoral nerve blocks is effective for reducing pain and postoperative opioid consumption undergoing mastectomy. This study was planned to evaluate the efficacy of intraoperative PECS block for postoperative analgesia after robot breast surgery and immediate breast reconstruction.

Detailed Description

Sixty patients were randomly allocated into two groups by computerised process, each including 30 patients. PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator. Control group(C) only received general anesthesia.

A Patient -controlled analgesia(PCA) device provides fentanyl for postoperative pain control.

The Primary outcome measures total dose of fentanyl consumption during the postoperative 24 hours, and secondary outcome measures pain scores at rest and movement.

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Study Start: 2020-07-08
• Primary Completion: 2021-10-10
• Study Completion: 2021-10-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 20years or older
2. Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction
3. American Society of Anesthesiologists(ASA) physical status I and III

Exclusion Criteria

1. Emergency operation
2. Reoperation
3. Patients with local anesthetic allergy
4. Patients with coagulopathy
5. Patients on anticoagulants
6. Patients who cannot use patient controlled analgesia(PCA)
7. Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
8. Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
9. Patients with history of heart failure (unstable angina, congestive heart failure)
10. Patients with history of liver failure, renal failure, allergic to medicine
11. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
12. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
13. Patients who cannot read the consent form (examples: Illiterate, foreigner)
14. Patients who withdraw the consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS block(P) group	pectoral nerve block	PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.

Primary Outcome Measures

Name	Time	Method
Total dose of fentanyl consumption during the postoperative 24h	after 24 hours postoperative period	To evaluate the effect of PECS block undergoing robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR), total cumulative dose of fentanyl was measured for the first postoperative 24h

Secondary Outcome Measures

Name	Time	Method
a numeric rating score at rest	24 hours after surgery	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement	24 hours after surgery	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

Trial Locations

Locations (1)

Yonsei Severance Hospital; 🇰🇷 Seoul, Korea, Republic of