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Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children

NCT ID: NCT02291692

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral block with bupivacaine on both perioperative anesthetic agent consumption and postoperative analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.

Detailed Description

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This study was performed after approval of Ethics Committee and parents written consent. Between the ages 1-5, planned percutaneous nephrolithotomy due to kidney stones 40 patients were enrolled in this study, and patients were randomly divided into two group. All patients were performed general anaesthesia. The Group I patients was given ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5 after giving prone position and the Group II patients was given 15 mg/kg of paracetamol as postoperative analgesia. In the period of postoperative, if the FLACC \> 4; it was planned to dose 1 mg/kg of tramadol. Patients' hemodynamic parameters, oxygen saturation, sevoflurane concentration were recorded 10, 15, 30 and 60 minutes intraoperatively. Patients' hemodynamic parameters, oxygen saturation, pain scores (FLACC), satisfaction of parents, the number of patients who additional analgesic requirements and side effects (nausea,vomiting, hypotension, bradycardia, respiration problems etc) were recorded in the postoperative period. Primary outcome measures was pain scores using FLACC scale.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Paravertebral blockade

Paravertebral blockade

Group Type ACTIVE_COMPARATOR

paravertebral blockade

Intervention Type PROCEDURE

ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5

Paracetamol

The patients was given 15 mg/kg of paracetamol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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paravertebral blockade

ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-II
* Between the ages of 1-5 years
* Forty children

Exclusion Criteria

* Refusals by parents
* Children with spine deformities
* Cutaneous infection
* Bleeding diathesis
* Allergy to drugs used
* ASA physical status III-IV
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Zehra

Zehra Hatipoglu

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülşah Akıncı, MD

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

References

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Berta E, Spanhel J, Smakal O, Smolka V, Gabrhelik T, Lonnqvist PA. Single injection paravertebral block for renal surgery in children. Paediatr Anaesth. 2008 Jul;18(7):593-7. doi: 10.1111/j.1460-9592.2008.02592.x. Epub 2008 May 8.

Reference Type BACKGROUND
PMID: 18482238 (View on PubMed)

Other Identifiers

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PVB

Identifier Type: -

Identifier Source: org_study_id