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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01549405
First received: March 7, 2012
Last updated: April 1, 2013
Last verified: April 2013
Results First Received: February 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor)
Condition: Nerve Block, Intercostal Nerve
Intervention: Other: İntercostal nerve block

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Group Control group: Group that without intercostal nerve block
Nerve Block

Group that performing intercostal block

İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.


Participant Flow:   Overall Study
    Control Group     Nerve Block  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group Control group: Group that without intercostal nerve block
Nerve Block

Group that performing intercostal block

İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.

Total Total of all reporting groups

Baseline Measures
    Control Group     Nerve Block     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  57.3  ± 7.4     53  ± 13.6     55.1  ± 10.2  
Gender  
[units: participants]
     
Female     6     7     13  
Male     14     13     27  
Region of Enrollment  
[units: participants]
     
Turkey     20     20     40  



  Outcome Measures
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1.  Primary:   Total Consumption of Tramadol Will be Measured for the First 24 Hours   [ Time Frame: Postoperative 24th hour ]

2.  Secondary:   Postoperative Pain Will be Evaluated.   [ Time Frame: 24 hours ]

3.  Primary:   Postoperative Analgesic (Tramadol) Consumption   [ Time Frame: Postoperative 24th hour ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Derya Özkan
Organization: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital
phone: 00903125962553
e-mail: derya_z@yahoo.com


No publications provided


Responsible Party: derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01549405     History of Changes
Other Study ID Numbers: Diskapi
Study First Received: March 7, 2012
Results First Received: February 21, 2013
Last Updated: April 1, 2013
Health Authority: Turkey: Ethics Committee