NCT04440995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

June 18, 2020

Last Update Submit

November 15, 2021

Conditions

Breast Neoplasm

Keywords

breast neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • a numeric rating score at rest

    0 hour after surgery

  • a numeric rating score at rest

    0.5 hour after surgery

  • a numeric rating score at rest

    1 hour after surgery

  • a numeric rating score at rest

    2 hours after surgery

  • a numeric rating score at rest

    4 hours after surgery

  • +13 more secondary outcomes

Study Arms (2)

PECS block(P) group

EXPERIMENTAL

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

Control(c) group

NO INTERVENTION

only received general anesthesia

Interventions

pectoral nerve blockPROCEDURE

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

PECS block(P) group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sun Jun Bai, Ph.D

    Severance Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 22, 2020

Study Start

July 8, 2020

Primary Completion

October 10, 2021

Study Completion

October 10, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)