NCT05170373

Brief Summary

Our study aimed to examine the effects of ultrasound guided erector spinae plane block in radical prostatectomy surgery on pain and surgical stress response, to reduce adrenocortical and sympathetic discharge due to anesthesia and surgery, and to reduce peroperative opioid analgesic consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

February 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

November 3, 2021

Last Update Submit

December 10, 2021

Conditions

Erector Spinae Plane Block

Keywords

Erektor Spinae Plane BlockPostoperative AnalgesiaSurgical Stress Response

Outcome Measures

Primary Outcomes (6)

  • Numeric Pain Scale

    Between 1-10. 1: no pain, 10: worst possible pain

    postoperative 24 hours.

  • Blood glucose

    mg /dL

    postoperative 24 hours.

  • insulin

    µIU/mL

    postoperative 24 hours.

  • cortisol

    µg/dL

    postoperative 24 hours.

  • prolactin

    µg/L

    postoperative 24 hours.

  • C-reactive protein

    mg/L

    postoperative 24 hours.

Secondary Outcomes (1)

  • Remifentanil Consumption Speed

    3 hours

Study Arms (2)

ESP group

ACTIVE COMPARATOR
Procedure: ESP block

control group

NO INTERVENTION

Interventions

ESP blockPROCEDURE

Before general anesthesia, ESP block was applied from the T12 vertebra level with 10 ml 0.5% bupivacaine HCL 5 ml 2% lidocaine HCL 5 ml 0.9% isotonic NaCl mixture

ESP group

Eligibility Criteria

Age30 Years - 74 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II

You may not qualify if:

  • diabetes
  • coagulopathy
  • local anesthetic
  • drug allergy
  • long hospitalization history,
  • hormone disorder
  • advanced organ failure
  • history of steroid use
  • vertebral anomalies
  • mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2021

First Posted

December 28, 2021

Study Start

February 1, 2019

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations

TU(1)