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Experimental for Inguinal Hernia
Phase 2 & 3
Waitlist Available
Led By Celia M Divino, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on post-op days 1-4
Summary
This trial tests if TAP blocks reduce pain and opioid use after inguinal hernia repair. It will also look for complications.
Eligible Conditions
- Inguinal Hernia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on post-op days 1-4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on post-op days 1-4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Score
Secondary study objectives
Number of Complications
Number of non-opioid pain medication
Number of opioid pills
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment2 Interventions
0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.
Group II: PlaceboPlacebo Group2 Interventions
Normal Saline:
For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.25% Bupivacaine
2011
Completed Phase 4
~520
TAP block
2010
Completed Phase 4
~1950
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,858 Total Patients Enrolled
Celia M Divino, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
48 Total Patients Enrolled
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