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Efficacy of Liposomal Bupivacaine for Pain Control After Percutaneous Nephrostolithotomy

NCT03043027 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-08-28

No results posted yet for this study

Summary

Percutaneous nephrostolithotomy (PCNL) is a common endoscopic procedure performed for upper urinary tract calculus disease. Despite being minimally invasive, it is associated with significant postoperative pain, often necessitating inpatient hospitalization and narcotic pain medications. Additionally, one of a number of catheters is often left protruding from the access tract for a period of time following the procedure, adding to patient discomfort. Attempts have been made to study peri-tubular or access tract analgesic installation, which have shown promise.1-2 However, no studies, to our knowledge, have examined the use of liposomal bupivacaine preparations in this regard. In this study we hope to prospectively analyze the use of liposomal bupivacaine injected to the access tract site at the time of PCNL and determine its effects on postoperative narcotic requirement and pain scores.

Patients presenting for PCNL will be randomized to either the liposomal bupivacaine or usual care, which involves no injection of local anesthesia. Patients will then be followed during their inpatient stay. Total narcotic requirement (in milligrams) and pain scores (using Wong-Baker FACES rating scale) will be compared.3 Typical postoperative care and discharge criteria will not change during the course of this study.

Conditions

  • Renal Calculi
  • Postoperative Pain

Interventions

DRUG

liposomal bupivicaine

local anesthetic

DRUG

Bupivacaine

local anesthetic

DRUG

Saline Solution

saline injection

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • David M Hoenig, md · Urologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-08
Primary Completion
2017-08-08
Completion
2017-08-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043027 on ClinicalTrials.gov