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This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.
The strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (ESWL), ureteroscopy, open surgery and percutaneous nephrolithotomy (PCNL). PCNL in an inpatient procedure performed in two steps. Step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. This step is typically performed by interventional radiologists under conscious sedation. Step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. The minimally invasive approach of PCNL is well accepted to be as effective as open procedures for stone removal with less morbidity. Post-operative pain management remains challenging and can lead to extended hospital stays.
This randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B- No Block | Placebo Comparator | Participants randodmized to this arm will have a local anesthetic injection and pressure applied to the paravertebral space. A paravertebral injection will not be conducted. |
|
| Group A- Paravertebral block | Active Comparator | Participants randodmized to this arm will have a local anesthetic (Bupivicaine 0.5% without epinephrine) injection and will be given a paravetebral block into the T10 paravertebral space.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A-Paravertebral block | Drug | Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | post-operative pain will be measured by the Visual Analog Scale (VAS. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opiod Use | All patients will receive the same post-operative pain control, which does not deviate from our standard protocol for patients receiving PCNL. All patients will be immediately given a PCA in recovery. Patients allergic to morphine/dilaudid will be given a narcoticopioid substitute (that will be converted to morphine equivalents for the purpose of the study). Nurses will be allowed to administer IV boluses of morphine PRN for inadequate pain control. If four boluses did not yield adequate analgesia, fentayl 50mcg will be used until adequate pain control is achieved. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Turk | Loyola Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2021 | |
| Reset | Jun 7, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2021 | Jun 7, 2021 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Group B- No block | Other | direct pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block. |
|
|
| 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |