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

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

Study Overview

• Status: Completed
• Conditions: Renal Stone
• Intervention / Treatment: Drug: Marcaine Injectable Product

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • Saddam Al Demour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Marcaine Injectable Product; Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration; Other Names: Sensorcaine Injectable Product
No Intervention: control group , no anesthesia infiltration post-op; control group: no anesthesia infiltration had been given post opertatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time for the first opioid demand	first post op time for analgesia	48 hours
the number of opioid demands	total number of opioid given to the patient	48 hours
total opioid consumption	total amount of opioid consumption	48 hours

Collaborators and Investigators

• Sponsor: Saddam Al Demour
• Investigators: Principal Investigator: Saddam AlDemour, professor, The University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Actual): September 12, 2020
• Study Completion (Actual): September 12, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 9, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Pain, Postoperative; Kidney Calculi; Nephrolithiasis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Sad2007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no IPD sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No