Phase 2 N=127 Randomized Double-blind Supportive Care

Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?

Ventral Hernia · Umbilical Hernia · Incisional Hernia · Postoperative Complications · Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT02007096 ↗

Enrolled (actual)

127

Serious AEs

—

Results posted

Jan 2018

Primary outcome: Primary: Post-operative Opioid Use — 10.59; 15.62; 16.09; 32.24 mg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Transabdominal Plane Block (Drug); Non Transabdominal Plane Block (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-operative Opioid Use	10.59; 15.62; 16.09; 32.24; 20.70; 39.37	—
SECONDARY Pain Score	4.60; 4.52; 6.75; 6.98	—
SECONDARY Operating Procedure Time	97.41; 98.81	—
SECONDARY Pain Score	4.60; 4.52; 6.75; 6.98	—

Summary

The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

Eligibility Criteria

Inclusion Criteria

age 18 and older
elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount Sinai Hospital

Exclusion Criteria

age younger than 18
allergic reaction to bupivacaine
allergic reaction to opioids
opioid substance abuse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02007096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.