NCT04706247

Brief Summary

The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 4, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2021

Completed
Last Updated

May 18, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 10, 2021

Last Update Submit

May 17, 2021

Conditions

PainBreast Diseases

Outcome Measures

Primary Outcomes (1)

  • Block success

    the number of patients whose surgery was completed without general anesthesia

    through study completion, an average of 3 months

Interventions

thoracic combined spinal epidural anesthesiaOTHER

A combined spinal-epidural anesthesia set will be used for the block. Using the loss of resistance to saline technique, an 18 G Tuohy needle will be advanced to the T2-3 vertebral interspace with the mid-line approach. After confirming the epidural space, a 26 G pencil point spinal needle will be inserted slowly through the Tuohy needle to puncture the dura. After free flow of cerebrospinal fluid will be observed, local anesthetic wil be injected into the subarachnoid space over 15 secs. Then, an epidural catheter will be inserted into the epidural space.

Eligibility Criteria

Age18 Months - 70 Months
Sexfemale
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Adults between 18-75 years of age and who will be to undergo elective breast surgery

You may qualify if:

  • Patients who will be to undergo elective surgery for breast surgery
  • American Society of Anesthesiologists (ASA) physical status classification groups I or II

You may not qualify if:

  • body mass index\>35 kg/m2,
  • presence of any condition complicating and contraindicating spinal epidural anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainBreast Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lutfi Ozyurek, M.D.

    Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 12, 2021

Study Start

January 4, 2021

Primary Completion

April 13, 2021

Study Completion

May 17, 2021

Last Updated

May 18, 2021

Record last verified: 2021-01

Locations

TU(1)