NCT04160936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2020

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.6 years

First QC Date

November 7, 2019

Last Update Submit

November 9, 2022

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • The time for the first opioid demand

    48 hours

  • the number of opioid demands

    48 hours

  • total opioid consumption

    48 hours

Study Arms (2)

study group :infiltration with 0.25% bupivacaine post-op

ACTIVE COMPARATOR

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

Drug: Marcaine Injectable Product

control group , no anesthesia infiltration post-op

NO INTERVENTION

control group: no anesthesia infiltration had been given post opertatively

Interventions

Marcaine Injectable ProductDRUG

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

Also known as: Sensorcaine Injectable Product
study group :infiltration with 0.25% bupivacaine post-op

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • body mass index \<35,
  • renal stone size \>2.0 cm.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saddam Al Demour

Amman, 11942, Jordan

Location

Related Publications (1)

  • Al Demour SH, Halalsheh OM, Al-Azab RS, Al-Zubi MT, Al-Rawashdah SF, Ibrahim MM, Abubaker AK, Aloweidi AS, Almustafa MM. The efficacy of bupivacaine infiltration along nephrostomy tract on postoperative pain control and opioid consumption after PCNL: a prospective randomized controlled trial. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):4951-4959. doi: 10.26355/eurrev_202306_32612.

    PMID: 37318469DERIVED

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Saddam AlDemour, professor

    The University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 13, 2019

Study Start

February 10, 2018

Primary Completion

September 12, 2020

Study Completion

September 12, 2020

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

no IPD sharing plan

Locations

JO(1)