NCT05513196

Brief Summary

The importance of effective postoperative pain management is well known. Overall, for total abdominal hysterectomy operations are related with severe postoperative pain. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Many regional anesthesia techniques can be preferred for total abdominal hysterectomy. The aim of this study is to investigate postoperative analgesia effect of erector spina plane block for total abdominal hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

November 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 23, 2021

Last Update Submit

November 7, 2022

Conditions

Keywords

postoperative paintotal abdominal hysterectomyerector spinae plan blockmorphinevisuel analog scale

Outcome Measures

Primary Outcomes (2)

  • Morphine consumption

    Morphine consumption (mg) of patients with patient controlled analgesia device

    Postoperative 24th hour

  • Visuel analog scale

    visuel analog scale of patients

    Postoperative 24th hour

Study Arms (2)

ESPB Group

Erector spinae plane block performed group.

Procedure: Erector spinae plane block (ESPB)

Control Group

Control group.

Interventions

Bilateral erector spinae plane block will be performed with 20 mL, 0.25% bupivacaine at T9 level preoperatively.

ESPB Group

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who undergo elective total abdominal hysterectomy surgery

You may qualify if:

  • ASA 1-2 patients
  • patients undergo elective total abdominal hysterectomy

You may not qualify if:

  • patient refusal
  • ASA 3-4
  • obesity (body mass index \>35 kg/m2)
  • infection of the skin at the site of needle puncture area patients
  • with known allergies to any of the study drugs
  • coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Izmit, 41350, Turkey (Türkiye)

Location

Related Publications (3)

  • Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.

    PMID: 29746445BACKGROUND
  • Hamed MA, Goda AS, Basiony MM, Fargaly OS, Abdelhady MA. Erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy: a randomized controlled study original study. J Pain Res. 2019 Apr 30;12:1393-1398. doi: 10.2147/JPR.S196501. eCollection 2019.

    PMID: 31118757BACKGROUND
  • De Cassai A, Geraldini F, Carere A, Sergi M, Munari M. Complications Rate Estimation After Thoracic Erector Spinae Plane Block. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):3142-3143. doi: 10.1053/j.jvca.2021.02.043. Epub 2021 Feb 20. No abstract available.

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • engin MD çetin

    Kocaeli Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 23, 2021

First Posted

August 24, 2022

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations