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Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children

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ClinicalTrials.gov Identifier: NCT02291692
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Zehra, Cukurova University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: paravertebral blockade Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Thoracic Paravertebral Block
Study Start Date : June 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Paravertebral blockade
Paravertebral blockade
Procedure: paravertebral blockade
ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5

No Intervention: Paracetamol
The patients was given 15 mg/kg of paracetamol.



Primary Outcome Measures :
  1. Pain score [ Time Frame: 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291692


Sponsors and Collaborators
Cukurova University
Investigators
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Principal Investigator: Gülşah Akıncı, MD Cukurova University
Publications:
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Responsible Party: Zehra, Zehra Hatipoglu, Cukurova University
ClinicalTrials.gov Identifier: NCT02291692    
Other Study ID Numbers: PVB
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations