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

Renal Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160936
• Other study ID #: Sad2007
• Status: Completed
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: September 12, 2020

Study information

• Verified date: November 2022
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 12, 2020
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Pain, Postoperative
• Renal Stone

Intervention

Drug:
• Marcaine Injectable Product
Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration

Locations

Country	Name	City	State
Jordan	Saddam Al Demour	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Saddam Al Demour

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	The time for the first opioid demand	first post op time for analgesia	48 hours
Secondary	the number of opioid demands	total number of opioid given to the patient	48 hours
Secondary	total opioid consumption	total amount of opioid consumption	48 hours