Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children

• Sponsor: Cukurova University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02291692
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 6

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jun 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pain score [12 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cukurova University

Investigators

• Principal Investigator: Gülşah Akıncı, MD, Cukurova University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Berta E, Spanhel J, Smakal O, Smolka V, Gabrhelik T, Lönnqvist 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.

• Responsible Party: Zehra, Zehra Hatipoglu, Cukurova University
• ClinicalTrials.gov Identifier: NCT02291692
• Other Study ID Numbers: PVB
• First Posted: Nov 14, 2014
• Last Update Posted: Nov 17, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Nov 17, 2014