Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy

April 1, 2013 updated by: derya özkan, Diskapi Teaching and Research Hospital
Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib level would alleviate postoperative pain and reduce analgesic consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients admitted for the removal of renal stones by PCNL will included in this study.Primary outcome measure will be analgesic (tramadol )consumption and visual analog scale (VAS).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Derya Ozkan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted for the removal of renal stones by percutaneous
  • nephrolithotomy (PCNL)
  • ASA I-II status

Exclusion Criteria:

  • Respiratory or cardiac disfunction
  • Neuropathy
  • Coagulopathy
  • BMI (Body mass index)over 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Control group: Group that without intercostal nerve block
Experimental: nerve block
Group that performing intercostal block
Other: İntercostal nerve block
Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Analgesic (Tramadol) Consumption
Time Frame: Postoperative 24th hour
Total consumption of tramadol will be measured for the first 24 hours.
Postoperative 24th hour
Total Consumption of Tramadol Will be Measured for the First 24 Hours
Time Frame: Postoperative 24th hour
Postoperative 24th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Will be Evaluated.
Time Frame: 24 hours
The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.("0" no pain, to "10", the maximum pain )Pain score less then 4 is acceptable.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Study Chair: Hamit Ersoy, MD, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
  • Study Director: Derya Özkan, MD, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
  • Principal Investigator: Taylan Akkaya, MD, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
  • Study Chair: Emine Arık, MD, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
  • Study Chair: Zeynep Koç, MD, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
  • Study Chair: Nihat Karakoyunlu, MD, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
  • Study Chair: Haluk Gümüs, MD, 1Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
  • Study Chair: Julide Ergil, MD, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Diskapi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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