Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
April 2, 2013
CompletedApril 2, 2013
April 1, 2013
6 months
March 7, 2012
February 21, 2013
April 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative Analgesic (Tramadol) Consumption
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
Postoperative 24th hour
Secondary Outcomes (1)
Postoperative Pain Will be Evaluated.
24 hours
Study Arms (2)
Control group
NO INTERVENTIONControl group: Group that without intercostal nerve block
nerve block
EXPERIMENTALGroup that performing intercostal block
Interventions
Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
Eligibility Criteria
You may qualify if:
- Patients admitted for the removal of renal stones by percutaneous
- nephrolithotomy (PCNL)
- ASA I-II status
You may not qualify if:
- Respiratory or cardiac disfunction
- Neuropathy
- Coagulopathy
- BMI (Body mass index)over 30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Derya Özkan
Ankara, 06110, Turkey (Türkiye)
Results Point of Contact
- Title
- Dr Derya Özkan
- Organization
- Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital
Study Officials
- 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
Hamit Ersoy, MD
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
- STUDY CHAIR
Julide Ergil, MD
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant of Anesthesiology ,MD
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 9, 2012
Study Start
February 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
April 2, 2013
Results First Posted
April 2, 2013
Record last verified: 2013-04