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The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.
The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone >2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group :infiltration with 0.25% bupivacaine post-op | Active Comparator | At the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin |
|
| control group , no anesthesia infiltration post-op | No Intervention | control group: no anesthesia infiltration had been given post opertatively |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine Injectable Product | Drug | Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale (VAS ) | Visual Analogue Scale (VAS), the patient is asked to describe the level of pain on a visual scale at rest at 1, 4, 8, 12, 24, and 48 hours | 1, 4, 8, 12, 24, and 48 hours |
| Dynamic Visual Analogue Scale (DVAS) | Dynamic Visual Analogue Scale (DVAS), the patient is asked to describe the level of pain on a visual scale during breathing at 1, 4, 8, 12, 24, and 48 hours | 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The time for the first opioid demand | first post op time for analgesia | 48 hours |
| the number of opioid demands | total number of opioid given to the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saddam AlDemour, professor | The University of Jordan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saddam Al Demour | Amman | 11942 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37318469 | Derived | Al Demour SH, Halalsheh OM, Al-Azab RS, Al-Zubi MT, Al-Rawashdah SF, Ibrahim MM, Abubaker AK, Aloweidi AS, Almustafa MM. The efficacy of bupivacaine infiltration along nephrostomy tract on postoperative pain control and opioid consumption after PCNL: a prospective randomized controlled trial. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):4951-4959. doi: 10.26355/eurrev_202306_32612. |
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no IPD sharing plan
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 48 hours |
| total opioid consumption | total amount of opioid consumption | 48 hours |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |