Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy
This study has been completed.
Sponsor:
Diskapi Teaching and Research Hospital
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Nerve Block, Intercostal Nerve |
Other: İntercostal nerve block |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
Further study details as provided by Diskapi Teaching and Research Hospital:
Primary Outcome Measures:
- Postoperative Analgesic (Tramadol) Consumption [ Time Frame: Postoperative 24th hour ] [ Designated as safety issue: Yes ]Total consumption of tramadol will be measured for the first 24 hours.
- Total Consumption of Tramadol Will be Measured for the First 24 Hours [ Time Frame: Postoperative 24th hour ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Postoperative Pain Will be Evaluated. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549405
Locations
| Turkey | |
| Derya Özkan | |
| Ankara, Turkey, 06110 | |
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | derya özkan, Consultant of Anesthesiology ,MD, 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 |
Keywords provided by Diskapi Teaching and Research Hospital:
|
percutanous nephrolitotomy,intercostal nerve block, Ultrasound |
ClinicalTrials.gov processed this record on June 18, 2013