NCT04296188

Brief Summary

The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Status
unknown

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 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

March 18, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

March 3, 2020

Last Update Submit

March 11, 2020

Conditions

Keywords

Pain ManagementQuality of Healthcare

Outcome Measures

Primary Outcomes (1)

  • Analgesic consumption

    Tramadol dose will be calculated as milligram

    From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours

Secondary Outcomes (3)

  • Postoperative pain intensity

    At 0,2,4,6,12,24th hours after surgery

  • Quality of recovery

    At postoperative 24th hours

  • The number of patients with perioperative side effects

    From 30 minute before surgery to postoperative 24th hours

Study Arms (2)

serratus anterior plane block

ACTIVE COMPARATOR

The serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.

Procedure: serratus anterior plane block

erector spina plane block

ACTIVE COMPARATOR

The erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.

Procedure: erector spina plane block

Interventions

ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.

serratus anterior plane block

ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.

erector spina plane block

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American society of score anesthesiologist I-II-III
  • Elective modified radical mastectomy
  • years old

You may not qualify if:

  • neurological disease
  • coagulopathy disease or using anticoagulants
  • non-cooperative
  • allergic to one of the drugs used in the study
  • recurrent breast cancer
  • body mass index is above 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

mehtap gürler balta, MD

CONTACT

tuğba karaman, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

March 18, 2020

Primary Completion

February 27, 2021

Study Completion

March 15, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03