Liposomal Bupivacaine vs Standard Penile Block for Hypospadias Repair

NCT04479371 | Withdrawn Phase 1

• 1 other identifier: STU-2020-0686
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigator proposes a prospective randomized study of males with hypospadias to either bupivacaine penile block or liposomal bupivacaine block for hypospadias repair, Figure 3. The investigator will use an envelope system for randomizing 1:1 to either group. Approach to surgery will be determined by the location of the urethral meatus and degree of chordee along with the amount of skin available and provider preference. Patients who have an ASA classification of 3 or greater, renal or hepatic dysfunction, less than 6 months of age, or refuse the risk of using liposomal bupivacaine during the procedure will be excluded. The goal is to compare the pain scores of standard bupivacaine penile blocks versus liposomal bupivacaine penile blocks for patients undergoing hypospadias surgery. This is also an opportunity to use liposomal bupivacaine in children as a regional local block for penile surgery. Patients will be enrolled at Children's Medical Center from July 1st, 2019 until 100 total patients are accrued, as specified in our sample size calculation. It is estimated that the trial will be completed in five years with hopes of potentially reaching 100 patients within two years.

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

• Difference in Mean Pain Scores recorded over the first 72 hours following surgery between the 2 arms

  Pain levels as indicated by the non-verbal Face, Legs, Activity, Cry, Consolability (FLACC) pain scale with liposomal vs standard bupivacaine. The scale allots each area mentioned in the acronym 0-2 points for a total scale of 0-10. 0 indicates no pain with greater scores indicating higher pain severity.

  For 72 hours following surgery

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

a penile block administered with novel liposomal bupivacaine during hypospadias repair

Drug: Liposomal bupivacaine

Standard Penile Block

ACTIVE COMPARATOR

Standard weight based bupivacaine penile block during hypospadias repair

Drug: Bupivacaine

Interventions

Liposomal bupivacaine DRUG

Injecting liposomal bupivacaine for a penile block for analgesia for hypospadias repair

Also known as: exparel

Liposomal bupivacaine

Bupivacaine DRUG

Standard bupivacaine

Also known as: 0.25% Bupivacaine

Standard Penile Block

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males aged 6 months to 24 months of all races and ethnicities that have hypospadias requiring surgical intervention and post-operative urethral catheterization.

You may not qualify if:

• Males who are not age 6 mo. to 24 months, those who do not have a diagnosis of hypospadias, those who have an ASA class of 3 or greater or known liver or renal impairment, or who have an allergy to local anesthetics such as lidocaine, bupivacaine, etc.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Related Publications (20)

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  BACKGROUND

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  PMID: 29299888 BACKGROUND

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• Gray, H., Anatomy of the human body. 20 ed. 1918, Philidelphia: Lea & Febiger. 968

  BACKGROUND

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  PMID: 8853095 BACKGROUND

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  PMID: 2672806 BACKGROUND

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  PMID: 12715136 BACKGROUND

• Pacira Pharmaceuticals. Exparel: Bupivacaine Liposome Injectable Suspension. [Prescribing Information]. Parsippany, NJ [Accessed August 23, 2018]. Available from: https://www.exparel.com/hcp/prescriptioninformation.pdf.

  BACKGROUND

• Wolfe JW, Butterworth JF. Local anesthetic systemic toxicity: update on mechanisms and treatment. Curr Opin Anaesthesiol. 2011 Oct;24(5):561-6. doi: 10.1097/ACO.0b013e32834a9394.

  PMID: 21841477 BACKGROUND

• Bergese SD, Onel E, Morren M, Morganroth J. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):145-51. doi: 10.1097/AAP.0b013e31823d0a80.

  PMID: 22266897 BACKGROUND

• Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12.

  PMID: 21842428 BACKGROUND

• Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

  PMID: 22285545 BACKGROUND

• Davidson EM, Barenholz Y, Cohen R, Haroutiunian S, Kagan L, Ginosar Y. High-dose bupivacaine remotely loaded into multivesicular liposomes demonstrates slow drug release without systemic toxic plasma concentrations after subcutaneous administration in humans. Anesth Analg. 2010 Apr 1;110(4):1018-23. doi: 10.1213/ANE.0b013e3181d26d2a.

  PMID: 20357145 BACKGROUND

• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.

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• Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012 Jan;32(1):69-76. doi: 10.1177/1090820X11430831. Epub 2011 Dec 16.

  PMID: 22179931 BACKGROUND

• Day KM, Nair NM, Sargent LA. Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Palatoplasty. J Craniofac Surg. 2018 Jul;29(5):e525-e528. doi: 10.1097/SCS.0000000000004591.

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• Manworren RC, Hynan LS. Clinical validation of FLACC: preverbal patient pain scale. Pediatr Nurs. 2003 Mar-Apr;29(2):140-6.

  PMID: 12723828 BACKGROUND

MeSH Terms

Conditions

Hypospadias

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Craig Peters, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded as to which block they received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Urology

Model Details: Two arms with one receiving liposomal bupivacaine in their penile block vs one receiving standard bupivacaine

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: July 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2023
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Until trial completion and data publication in 2023
• Access Criteria: Research team only