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

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Yonsei University

Status

Completed

Conditions

Breast Neoplasm

Treatments

Procedure: pectoral nerve block

Study type

Interventional

Funder types

Other

Identifiers

NCT04440995
4-2020-0430

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

PECS block(P) group
Experimental group
Description:
PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.
Treatment:
Procedure: pectoral nerve block
Control(c) group
No Intervention group
Description:
only received general anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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