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Completed

NCT Number: NCT04440995

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

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.

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

pectoral nerve block

Procedure

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

Primary outcomes

  1. Total dose of fentanyl consumption during the postoperative 24h

    Time frame: 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 outcomes

  1. a numeric rating score at rest

    Time frame: 0 hour after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  2. a numeric rating score at rest

    Time frame: 0.5 hour after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  3. a numeric rating score at rest

    Time frame: 1 hour after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  4. a numeric rating score at rest

    Time frame: 2 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  5. a numeric rating score at rest

    Time frame: 4 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  6. a numeric rating score at rest

    Time frame: 6 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  7. a numeric rating score at rest

    Time frame: 8 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  8. a numeric rating score at rest

    Time frame: 12 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  9. a numeric rating score at rest

    Time frame: 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)

  10. a numeric rating score at movement

    Time frame: 0 hour after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  11. a numeric rating score at movement

    Time frame: 0.5 hour after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  12. a numeric rating score at movement

    Time frame: 1 hour after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  13. a numeric rating score at movement

    Time frame: 2 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  14. a numeric rating score at movement

    Time frame: 4 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  15. a numeric rating score at movement

    Time frame: 6 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  16. a numeric rating score at movement

    Time frame: 8 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  17. a numeric rating score at movement

    Time frame: 12 hours after surgery

    Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)

  18. a numeric rating score at movement

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2020
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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