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The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy

The Effect of Peritubal Infiltration With Bupivacaine Around Nephrostomy Tract on Postoperative Pain Control After Percutaneous Nephrolithotomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04160936
Enrollment
50
Registered
2019-11-13
Start date
2018-02-10
Completion date
2020-09-12
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone

Brief summary

The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.

Detailed description

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.

Interventions

Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration

Sponsors

Saddam Al Demour
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 18-70 years of age * body mass index \<35, * renal stone size \>2.0 cm.

Exclusion criteria

* patients having supra-costal puncture. * excessive intraoperative bleeding. * renal stones requiring more than a single puncture. * surgical procedure extending more than 3 hours. * urinary tract infection. * severe cardiopulmonary disease. * abnormal renal function tests. * allergy to local anesthetics.

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale (VAS )1, 4, 8, 12, 24, and 48 hoursVisual 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
Dynamic Visual Analogue Scale (DVAS)1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hoursDynamic 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

Secondary

MeasureTime frameDescription
The time for the first opioid demand48 hoursfirst post op time for analgesia
the number of opioid demands48 hourstotal number of opioid given to the patient
total opioid consumption48 hourstotal amount of opioid consumption

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026