NCT05672680

Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

Completed Phase 2, PHASE3 Results posted Last updated 28 March 2025

What this trial tests

Phase 2, PHASE3 trial testing 0.25% Bupivacaine in Inguinal Hernia in 100 participants. Completed in 3 August 2023.

Timeline

9 December 2019

Primary endpoint
3 August 2023

3 August 2023

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	9 December 2019
Primary completion	3 August 2023
Estimated completion	3 August 2023
Sites	1 location across United States

Drugs / interventions tested

• 0.25% Bupivacaine — full drug profile →
• Placebo
• TAP block

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Score at Rest Primary · on post-op days 1, 2, 3, and 4

On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain.

post-op day 1

Group	Value	95% CI
Placebo	4.31	± 2.46
Experimental	4.55	± 2.70

post-op day 2

Group	Value	95% CI
Placebo	4.21	± 2.49
Experimental	4.53	± 2.61

post-op day 3

Group	Value	95% CI
Placebo	3.53	± 2.39
Experimental	3.77	± 2.49

post-op day 4

Group	Value	95% CI
Placebo	2.92	± 2.39
Experimental	3.19	± 2.46

Pain Score at Rest Primary · All post-op (average 4 days)

On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain.

Group	Value	95% CI
Placebo	3.75	± 2.48
Experimental	4.01	± 2.65

Pain Score at Movement Primary · on post-op days 1, 2, 3, and 4

On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain.

post-op day 1

Group	Value	95% CI
Placebo	5.84	± 2.42
Experimental	6.35	± 2.54

post-op day 2

Group	Value	95% CI
Placebo	5.47	± 2.56
Experimental	6.16	± 2.55

post-op day 3

Group	Value	95% CI
Placebo	4.65	± 2.21
Experimental	4.99	± 2.51

post-op day 4

Group	Value	95% CI
Placebo	3.71	± 2.37
Experimental	4.31	± 2.53

Pain Score at Movement Primary · All post-op (average 4 days)

On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain.

Group	Value	95% CI
Placebo	4.93	± 2.51
Experimental	5.46	± 2.67

Number of Opioid Pills Secondary · on post-op days 1, 2, 3, and 4

Patients recorded the number of opioid pills taken.

post-op day 1

Group	Value	95% CI
Placebo	1.29	± 1.47
Experimental	1.52	± 1.28

post-op day 2

Group	Value	95% CI
Placebo	1.25	± 1.62
Experimental	1.35	± 1.48

post-op day 3

Group	Value	95% CI
Placebo	0.88	± 1.45
Experimental	0.60	± 1.10

post-op day 4

Group	Value	95% CI
Placebo	1.21	± 1.54
Experimental	0.77	± 1.26

Number of Opioid Pills Secondary · All post-op (average 4 days)

Patients recorded the number of opioid pills taken.

Group	Value	95% CI
Placebo	1.16	± 1.52
Experimental	1.06	± 1.33

Number of Non-opioid Pain Medication Secondary · on post-op days 1, 2, 3, and 4

Patients recorded the number of non-opioid pills taken for pain control.

post-op day 1

Group	Value	95% CI
Placebo	0.76	± 1.03
Experimental	0.71	± 1.09

post-op day 2

Group	Value	95% CI
Placebo	1.07	± 1.22
Experimental	0.78	± 1.05

post-op day 3

Group	Value	95% CI
Placebo	0.85	± 1.04
Experimental	0.77	± 0.96

post-op day 4

Group	Value	95% CI
Placebo	0.77	± 0.98
Experimental	0.65	± 0.82

Number of Non-opioid Pain Medication Secondary · All post-op (average 4 days)

Patients recorded the number of non-opioid pills taken for pain control.

Group	Value	95% CI
Placebo	0.86	± 1.07
Experimental	0.73	± 0.98

Number of Intraoperative Complications Secondary · up to 2 weeks post-surgery

Chart review complications recorded. These are considered expected intraoperative complications and are not considered as adverse events based on research procedures.

Mortality

Group	Value	95% CI
Placebo	0
Experimental	0

Urinary Retention

Group	Value	95% CI
Placebo	1
Experimental	2

Early Recurrence

Group	Value	95% CI
Placebo	0
Experimental	1

Hematoma

Group	Value	95% CI
Placebo	0
Experimental	1

Induration

Group	Value	95% CI
Placebo	1
Experimental	1

Number of Participants With Contents in the Hernia Secondary · during procedure

Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder.

Group	Value	95% CI
Placebo	33
Experimental	39
Placebo	1
Experimental	0
Placebo	10
Experimental	6
Placebo	0
Experimental	1

Number of Surgical Tacks Used Per Repair Secondary · during procedure

Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain.

Group	Value	95% CI
Placebo	16
Experimental	12
Placebo	0
Experimental	3
Placebo	18
Experimental	15
Placebo	10
Experimental	16

Procedure Time Secondary · during procedure

Procedure duration in minutes.

Group	Value	95% CI
Placebo	72.7	± 19.13
Experimental	78.54	± 27.20

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.