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

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440995
• Other study ID #: 4-2020-0430
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: October 10, 2021

Study information

• Verified date: November 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 10, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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