Hypospadias Clinical Trial
Official title:
Prospective Randomized Trial of Penile Nerve Block With Liposomal Bupivacaine for Hypospadias Repair vs Standard Penile Block With Bupivacaine
Verified date | August 2021 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 30, 2023 |
Est. primary completion date | July 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 6 Months to 24 Months |
Eligibility | Inclusion Criteria: - Males aged 6 months to 24 months of all races and ethnicities that have hypospadias requiring surgical intervention and post-operative urethral catheterization. Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Texas Southwestern Medical Center |
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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