Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

Study Overview
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Brief Summary
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The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Detailed Description
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The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Official Title
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Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.

Conditions
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Pain, Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.
* Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients undergoing PCNL age from 12-65 years normal renal functions no history of chronic pain ASA I, II & III Both genders Exclusion Criteria: history of local anaesthesia allergy Redo PCNL Multiple punctures during PCNL Excessive intra-operative bleeding Diabetes mellitus Coagulopathy Mental disorder ASA IV & V Active urinary tract infection.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Local Anesthesia<br>Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine. | Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.<br>* Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.<br>* Other names: Local Anesthesia;Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.<br>* Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required<br>* Other names: Intravenous analgesic;|
| Other: Intravenous Analgesics<br>Group B patients received postoperative intravenous analgesia. | Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.<br>* Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.<br>* Other names: Local Anesthesia;Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.<br>* Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required<br>* Other names: Intravenous analgesic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy. | Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL. Measurement: Postoperative pain Measurement tool: Visual analog scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local anesthesia, Percutaneous nephrolithotomy.