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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Control group: Group that without intercostal nerve block | |
| nerve block | Experimental | Group that performing intercostal block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| İntercostal nerve block | Other | Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Will be Evaluated. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derya Özkan, MD | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic | Study Director |
| Taylan Akkaya, MD | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derya Özkan | Ankara | 06110 | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control group: Group that without intercostal nerve block |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control group: Group that without intercostal nerve block |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Analgesic (Tramadol) Consumption | Total consumption of tramadol will be measured for the first 24 hours. | Not Posted | Postoperative 24th hour | ||||||||||||
| Secondary | Postoperative Pain Will be Evaluated. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Group that without intercostal nerve block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Derya Özkan | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital | 00903125962553 | derya_z@yahoo.com |
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| Study Chair |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Primary | Total Consumption of Tramadol Will be Measured for the First 24 Hours | Posted | Mean | Standard Deviation | mg | Postoperative 24th hour |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | İntercostal Nerve Block | Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery. | 0 | 20 | 0 | 20 |
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