Efficacy of Liposomal Bupivacaine for Pain Control After Percutaneous Nephrostolithotomy

NCT03043027 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: IRB# 16-748
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Scores from the Visual Analog Scale for pain 24 hours post-procedurally in the liposomal bupivacaine group and the bupivacaine group

  Scores from the Visual Analog Scale for pain 24 hours post-procedurally in the liposomal bupivacaine group and the bupivacaine group

  24 hours

Secondary Outcomes (1)

• narcotic usage

  pain scores at 6, 12, 24, and 48 hours

Study Arms (3)

Liposomal bupivicaine

EXPERIMENTAL

Drug: liposomal bupivicaine

bupivicaine

ACTIVE COMPARATOR

Drug: Bupivacaine

saline

PLACEBO COMPARATOR

Drug: Saline Solution

Interventions

liposomal bupivicaine DRUG

local anesthetic

Liposomal bupivicaine

Bupivacaine DRUG

local anesthetic

bupivicaine

Saline Solution DRUG

saline injection

saline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years old
• Patients with calculus disease that can be treated with PCNL

You may not qualify if:

• Patients \<18 years old.
• Patients who are not able to give consent for study
• Patients with active urinary tract infection
• Pregnant women
• Patients with hepatic insufficiency
• Patients with more than 2 access tracts created
• Allergies to bupivacaine or liposomal bupivacaine
• Patients with chronic pain syndromes as determined by using \>30mg oral morphine equivalents per day
• Patients who are neurologically impaired and may have altered pain sensation due to previous diseases (e.g. paraplegics, quadriplegics, systemic neurological condition, etc.)
• Patients who are undergoing staged procedures during that same hospital stay
• Patients who are placed on patient controlled analgesia or patient controlled epidural analgesia
• Patients who remain intubated after surgery
• Patients who will have ureteral stents
• Patients who do not require care in the intensive care unit
• Patients who are mentally impaired.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (6)

• Jonnavithula N, Pisapati MV, Durga P, Krishnamurthy V, Chilumu R, Reddy B. Efficacy of peritubal local anesthetic infiltration in alleviating postoperative pain in percutaneous nephrolithotomy. J Endourol. 2009 May;23(5):857-60. doi: 10.1089/end.2008.0634.

  PMID: 19397429 BACKGROUND

• Lojanapiwat B, Chureemas T, Kittirattarakarn P. The efficacy of peritubal analgesic infiltration in postoperative pain following percutaneous nephrolithotomy - A prospective randomized controlled study. Int Braz J Urol. 2015 Sep-Oct;41(5):945-52. doi: 10.1590/S1677-5538.IBJU.2014.0471.

  PMID: 26689520 BACKGROUND

• Cherian JJ, Barrington J, Elmallah RK, Chughtai M, Mistry JB, Mont MA. Liposomal Bupivacaine Suspension, Can Reduce Length of Stay and Improve Discharge Status of Patients Undergoing Total Hip Arthroplasty. Surg Technol Int. 2015 Nov;27:235-9.

  PMID: 26680403 BACKGROUND

• Marcet JE, Nfonsam VN, Larach S. An extended paIn relief trial utilizing the infiltration of a long-acting Multivesicular liPosome foRmulation Of bupiVacaine, EXPAREL (IMPROVE): a Phase IV health economic trial in adult patients undergoing ileostomy reversal. J Pain Res. 2013 Jul 18;6:549-55. doi: 10.2147/JPR.S46467. Print 2013.

  PMID: 23901290 BACKGROUND

• Vogel JD. Liposome bupivacaine (EXPAREL(R)) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial. J Pain Res. 2013 Jul 29;6:605-10. doi: 10.2147/JPR.S46950. Print 2013.

  PMID: 23935387 BACKGROUND

• Hu D, Onel E, Singla N, Kramer WG, Hadzic A. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig. 2013 Feb;33(2):109-15. doi: 10.1007/s40261-012-0043-z.

  PMID: 23229686 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• David M Hoenig, md

  Urologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: February 3, 2017
• Study Start: August 8, 2017
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)