Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children

Postoperative Pain Clinical Trial

Official title:

Ultrasound Guided Thoracic Paravertebral Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291692
• Other study ID #: PVB
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2014
• Last updated: November 14, 2014
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• paravertebral blockade
ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score		12 hours	No