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

Not Applicable

Completed

• Conditions: Renal Stone
• Interventions: Drug: Marcaine Injectable Product

• Registration Number: NCT04160936
• Lead Sponsor: Saddam Al Demour

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.

Study Timeline

• Study Start: 2018-02-10
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-09
• Study First Posted: 2019-11-13
• Primary Completion: 2020-09-12
• Study Completion: 2020-09-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group :infiltration with 0.25% bupivacaine post-op	Marcaine Injectable Product	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

Primary Outcome Measures

Name	Time	Method
visual analogue scale (VAS )	1, 4, 8, 12, 24, and 48 hours	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
Dynamic Visual Analogue Scale (DVAS)	1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours	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

Secondary Outcome Measures

Name	Time	Method
The time for the first opioid demand	48 hours	first post op time for analgesia
the number of opioid demands	48 hours	total number of opioid given to the patient
total opioid consumption	48 hours	total amount of opioid consumption

Trial Locations

Locations (1)

Saddam Al Demour; 🇯🇴 Amman, Jordan