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Clinical Trials/NCT04160936
NCT04160936
Completed
Not Applicable

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

Saddam Al Demour1 site in 1 country50 target enrollmentFebruary 10, 2018

Overview

Phase
Not Applicable
Intervention
Marcaine Injectable Product
Conditions
Renal Stone
Sponsor
Saddam Al Demour
Enrollment
50
Locations
1
Primary Endpoint
visual analogue scale (VAS )
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 10, 2018
End Date
September 12, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Saddam Al Demour
Responsible Party
Sponsor Investigator
Principal Investigator

Saddam Al Demour

Assistant Professor

University of Jordan

Eligibility Criteria

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.

Arms & Interventions

study group :infiltration with 0.25% bupivacaine post-op

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

Intervention: Marcaine Injectable Product

Outcomes

Primary Outcomes

visual analogue scale (VAS )

Time Frame: 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)

Time Frame: 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 Outcomes

  • The time for the first opioid demand(48 hours)
  • the number of opioid demands(48 hours)
  • total opioid consumption(48 hours)

Study Sites (1)

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