NCT03899545

Brief Summary

Breast cancer is the most common malignancy in women at worldwide. Even a minor breast surgery can cause significant postoperative pain (PP) (1). PP could be converted into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delay in wound healing, prolonged hospital stay, increased opioid use, increased side effects and high cost of care. For these reasons, regional anesthetic techniques are recommended for effective PP management. Some of recent studies suggest that ultrasound-guided pectoral I (PI), pectoral II (PII) and serratus plan block (SPB) may be an alternative to thoracic epidural analgesia and paravertebral block applications because of the ease of administration, low side effect profile and adequate analgesia in breast surgery. (2,3).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable postoperative-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

April 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

March 31, 2019

Last Update Submit

February 24, 2020

Conditions

Postoperative PainPostoperative NauseaPatient SatisfactionNarcotic Use

Keywords

serratus plane blockpectoral I blockbreast cancer surgeryperioperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Pain intensity score

    Self reported pain intensity in the postoperative 0, 1,2,6,12 and 24 hour. Each item is scored 0-10 (0: no pain 10: pain as bad as can be)

    24 hour

Secondary Outcomes (5)

  • İntraoperative fentanyl requirement

    during surgery

  • time to first analgesic request

    24 hour

  • Postoperative opioid consumption

    24 hour

  • Postoperative nausea and vomiting

    24 hour

  • Patient satisfaction: score

    24 hour

Study Arms (2)

Serratus Plane Block

EXPERIMENTAL

Serratus plane block will be applied after induction of general anesthesia.

Other: Serratus Plane Block

Serratus Plane Block plus Pectoral I block

ACTIVE COMPARATOR

Serratus plane plus pectoral I block will be applied after induction of general anesthesia.

Other: Serratus Plane Block plus Pectoral I Block

Interventions

Serratus Plane BlockOTHER

0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle

Serratus Plane Block
Serratus Plane Block plus Pectoral I BlockOTHER

0.5 ml / kg %0.25 Bupivacaine/ %1 lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.2/3 of the total drug will be applied for the serratus plane block and 1/3 of the total drug for the pectoral I block. If the total amount of the drug is less than 30 ml, it will be completed with isotonic saline to 30 ml.

Serratus Plane Block plus Pectoral I block

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2-3
  • Patients scheduled for elective surgery

You may not qualify if:

  • Previous neurological disease symptom (TIA, syncope, dementia, etc.)
  • Allergy to drugs
  • Major cardiac disease
  • Renal failure
  • Psychiatric disease
  • Patients who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • Yesiltas S, Turkoz A, Calim M, Yilmaz S, Esen A, Daskaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14.

    PMID: 35221650DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingPatient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomitingTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Serdar Yeşiltaş, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 2, 2019

Study Start

April 6, 2019

Primary Completion

September 5, 2019

Study Completion

September 20, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)