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

The Effects of Perioperative PECS Block on Postoperative Pain Control During Robotic Breast Surgery and Breast Reconstruction - Double Blind Randomized Controlled Trial -

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm
• Intervention / Treatment: Procedure: pectoral nerve block

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PECS block(P) group; PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.	Procedure: pectoral nerve block; Patients received standardized general anesthesia. PECS block were applied under vision using blunted tip cannula(27G, 30mm) after surgical resection of breast by operator. 0.25% ropivacaine 10ml was injected into fascia between pectoralis major and minor muscles. 0.25% ropivacaine 20ml was injected into fascia between pectoralis minor and serratus anterior muscles at the level of the third rib. Breast reconstruction is performed after PECS block
No Intervention: Control(c) group; only received general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of fentanyl consumption during the postoperative 24h	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	after 24 hours postoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	0 hour after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	0.5 hour after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	1 hour after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	2 hours after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	4 hours after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	6 hours after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	8 hours after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	12 hours after surgery
a numeric rating score at rest	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	24 hours after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	0 hour after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	0.5 hour after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	1 hour after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	2 hours after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	4 hours after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	6 hours after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	8 hours after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	12 hours after surgery
a numeric rating score at movement	Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)	24 hours after surgery

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Study Director: Sun Jun Bai, Ph.D, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): October 10, 2021
• Study Completion (Actual): October 10, 2021

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: breast neoplasms
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 4-2020-0430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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