Clinical trial NCT04440995: The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction
Official title: The Effects of Perioperative PECS Block on Postoperative Pain Control During Robotic Breast Surgery and Breast Reconstruction - Double Blind Randomized Controlled Trial -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Keywords: breast neoplasms
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total dose of fentanyl consumption during the postoperative 24h
timeFrame: after 24 hours postoperative period
Secondary outcomes:
measure: a numeric rating score at rest
timeFrame: 0 hour after surgery
measure: a numeric rating score at rest
timeFrame: 0.5 hour after surgery
measure: a numeric rating score at rest
timeFrame: 1 hour after surgery
measure: a numeric rating score at rest
timeFrame: 2 hours after surgery
measure: a numeric rating score at rest
timeFrame: 4 hours after surgery
measure: a numeric rating score at rest
timeFrame: 6 hours after surgery
measure: a numeric rating score at rest
timeFrame: 8 hours after surgery
measure: a numeric rating score at rest
timeFrame: 12 hours after surgery
measure: a numeric rating score at rest
timeFrame: 24 hours after surgery
measure: a numeric rating score at movement
timeFrame: 0 hour after surgery
measure: a numeric rating score at movement
timeFrame: 0.5 hour after surgery
measure: a numeric rating score at movement
timeFrame: 1 hour after surgery
measure: a numeric rating score at movement
timeFrame: 2 hours after surgery
measure: a numeric rating score at movement
timeFrame: 4 hours after surgery
measure: a numeric rating score at movement
timeFrame: 6 hours after surgery
measure: a numeric rating score at movement
timeFrame: 8 hours after surgery
measure: a numeric rating score at movement
timeFrame: 12 hours after surgery
measure: a numeric rating score at movement
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Sun Jun Bai, Ph.D
role: STUDY_DIRECTOR
References: