NCT04406012

Brief Summary

The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2016

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

May 23, 2020

Last Update Submit

September 26, 2020

Conditions

Keywords

Pain managementAnalgesiaparavertebral blocknephrolithotomy

Outcome Measures

Primary Outcomes (1)

  • Patient VAS scores

    0=no pain, 10=incredible pain

    24 hours

Secondary Outcomes (1)

  • Patient Satisfaction scores

    at the end of the 24 hours

Study Arms (2)

block group

ACTIVE COMPARATOR

Paravertebral group at Thoracic 9-10 vertebrae level with an in-plane technique advanced ultrasound guided 10 ml bupivacaine hydrochloride (Marcaine 0.5%, Astra Zeneca) in 20 ml volume was enjected in the paravertebral area with real-time visualisation It was observed that the local anesthetic drug spread on the pleura and the pleura was pushed. All blocks were performed by the same experienced anaesthesiologist.

Procedure: paravertebral block

Control group

NO INTERVENTION

Conventional analgesia methods were applied to the control group. Control group was relieved by dexketoprofen 50mg intravenously. If the patient was not relieved with dexketoprofen and VAS score \>4, tramadol 1 mg kg-1 was administered intravenously.

Interventions

paravertebral block group

block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
ASA I, II, III patients aged 18-65 who consented to undergo unilateral percutaneous nephrolithotomy were eligible for the study. 53 patients were eligible and assesed.Informed consent was signed by all patients. Patients under 18 years of age, pregnant, with known hypersensitivity to local anesthetics, bleeding diathesis, depression and / or anxiety disorder, obesity (BMI\> 35kg / m2), history of pneumothorax, phrenic nerve paralysis, severe aortic stenosis were excluded. Also who did not want to participate the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Yaman F, Tuglu D. Analgesic efficacy of ultrasound guided paravertebral block in percutaneous nephrolithotomy patients: a randomized controlled clinical study. BMC Anesthesiol. 2020 Sep 29;20(1):250. doi: 10.1186/s12871-020-01169-6.

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Paravertebral block group and Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

May 23, 2020

First Posted

May 28, 2020

Study Start

February 16, 2016

Primary Completion

June 16, 2016

Study Completion

July 1, 2016

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

when the article published