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Completed

NCT Number: NCT04160936

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

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

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Key information

Conditions

Renal Stone Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saddam Al Demour

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Marcaine Injectable Product

Drug

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

Other names: Sensorcaine Injectable Product

Primary outcomes

  1. 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

  2. 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

  1. The time for the first opioid demand

    Time frame: 48 hours

    first post op time for analgesia

  2. the number of opioid demands

    Time frame: 48 hours

    total number of opioid given to the patient

  3. total opioid consumption

    Time frame: 48 hours

    total amount of opioid consumption

Sponsors and collaborators

Lead sponsor

Saddam Al Demour

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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