Phase 3
N=100
Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
Inguinal Hernia
Bottom Line
View on ClinicalTrials.gov: NCT05672680 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Pain Score at Rest — 4.31; 4.55; 4.21; 4.53 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.25% Bupivacaine (Drug); Placebo (Drug); TAP block (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score at Rest |
3.75; 4.01 | — |
| PRIMARY Pain Score at Rest |
3.75; 4.01 | — |
| PRIMARY Pain Score at Movement |
4.93; 5.46 | — |
| PRIMARY Pain Score at Movement |
4.93; 5.46 | — |
| SECONDARY Number of Opioid Pills |
1.16; 1.06 | — |
| SECONDARY Number of Opioid Pills |
1.16; 1.06 | — |
| SECONDARY Number of Non-opioid Pain Medication |
0.86; 0.73 | — |
| SECONDARY Number of Non-opioid Pain Medication |
0.86; 0.73 | — |
| SECONDARY Number of Intraoperative Complications |
0; 0; 1; 2; 0; 1 | — |
| SECONDARY Number of Participants With Contents in the Hernia |
33; 39; 1; 0; 10; 6 | — |
| SECONDARY Number of Surgical Tacks Used Per Repair |
16; 12; 0; 3; 18; 15 | — |
| SECONDARY Procedure Time |
72.7; 78.54 | — |
| SECONDARY Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss |
38; 39; 5; 7; 1; 0 | — |
| SECONDARY Number of Patients Per Anesthesiologist |
18; 21; 3; 2; 7; 4 | — |
Summary
The aim of this double-blind clinical trial is to examine outcomes and pain control after surgery in patients who underwent laparoscopic inguinal hernia repair (IHR) with the use of perioperative transabdominal plane (TAP) block.
Research Question: Does transabdominal plane block improve pain when undergoing inguinal hernia repair? The endpoints include whether preoperative TAP blocks improve pain score (primary end point) and decrease opioid use (secondary endpoint) after an inguinal hernia repair. Other end points- complications after surgery.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital
Exclusion Criteria
- patients who are younger than 18 years old,
- have a history of chronic opiate usage, liver or kidney disease, pain syndromes,
- allergy to bupivacaine,
- are pregnant or
- are unable to independently give consent
Data sourced from ClinicalTrials.gov (NCT05672680). 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.