NCT05674006

Brief Summary

The goal of this retrospective observational study is to demonstrate investigators' experience of Ultrasound guided Sacral Erector Spina Plane Block as an anesthetic technique in patients underwent sacral plastic and reconstructive surgeries. The main question\[s\] it aims to answer are:

  • block indication, level
  • results, side effects and complications

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

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

First Submitted

Initial submission to the registry

December 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

December 30, 2022

Last Update Submit

March 16, 2023

Conditions

Keywords

AnesthesiaESPSacral

Outcome Measures

Primary Outcomes (1)

  • Block success

    Effectiveness of Sacral Erector Spinae Plane Block as an Anesthetic technique

    up to 1 year

Secondary Outcomes (1)

  • Number and amount of required perioperative analgesic/anesthetic drugs

    up to 2 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All ASA1-4 patients of age older than18 going for a sacral surgery

You may qualify if:

  • being going for a sacral surgery
  • American Society of Anesthesiology status (ASA) 1 - 4

You may not qualify if:

  • emergency
  • ASA-5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (4)

  • Unal Artik HA, Gulpinar TO, Halis A, Celebi N. Erector spinae plane block in chronic pain: a retrospective study. Turk J Med Sci. 2022 Aug;52(4):1408-1410. doi: 10.55730/1300-0144.5449. Epub 2022 Aug 10.

    PMID: 36326408BACKGROUND
  • Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.

    PMID: 33585088BACKGROUND
  • Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.

    PMID: 32158307BACKGROUND
  • Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.

    PMID: 30999197BACKGROUND

Study Officials

  • Serkan Tulgar

    Samsun University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 6, 2023

Study Start

January 25, 2023

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations