NCT02291692

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4 postoperative-pain

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

June 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

November 7, 2014

Last Update Submit

November 14, 2014

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score

    12 hours

Study Arms (2)

Paravertebral blockade

ACTIVE COMPARATOR

Paravertebral blockade

Procedure: paravertebral blockade

Paracetamol

NO INTERVENTION

The patients was given 15 mg/kg of paracetamol.

Interventions

paravertebral blockadePROCEDURE

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

Paravertebral blockade

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18482238BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gülşah Akıncı, MD

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zehra Hatipoglu

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 14, 2014

Study Start

June 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

November 17, 2014

Record last verified: 2014-11