Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study

July 28, 2022 updated by: Sibel Seçkin Pehlivan, TC Erciyes University
To evaluate the ability of Erector spina Plane block decrease postoperative pain and analgesia requirements in patients undergoing Percutaneous Nephrolithotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Erector spina Plane block was performed with guided ultrasound at T10 Transverse process level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy surgeries.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Talas
      • Kayseri, Talas, Turkey, 38039
        • Sibel Seçkin Pehlivan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A number of 60 patients undergoing PCNL between January 2019 and December 2019 were included in our study. Patients included in the study were those who were operated from the stone diseases.

Description

Inclusion Criteria:

  • ASA I- ASA II Patients

Exclusion Criteria:

  • history of allergy to the study medication
  • refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Erector spinae plane block group (ESP)
Single- shot ultrasound guided ESP block with 30 ml 0.25% bupivacain at the T10 vertebral level was performed preoperatively to patients in the ESP group (Group I).
Procedure: Erector Spinae Plane block ( Group I)
ESP Block was performed preoperative to all patients in ESP block group. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
non- blocked Group
consists of the patient group without any procedure
Procedure: non- blocked Group (GROUP II)
This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal analog Pain Scores on rest and movement
Time Frame: 24 hours after surgery
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
24 hours after surgery
opioid consumption
Time Frame: 24 hours after surgery
In the recovery room, all patients were given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time and 10 mg 4 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: 24 hours after surgery
Age, BMI, ASA, Duration of surgery was recorded.
24 hours after surgery
incidences of adverse effects (like nausea and vomiting)
Time Frame: 24 hours after surgery
incidences of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Study Director: Sibel Pehlivan, TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (ACTUAL)

April 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/881

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 24 months of study completion

IPD Sharing Access Criteria

Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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