Inguinal HerniaPhase 2/3NCT05672680

Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

A Phase 2/3 study testing 0.25% Bupivacaine and TAP block in people with Inguinal Hernia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inguinal Hernia
What is being tested?: 0.25% Bupivacaine and TAP block
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 9 Dec 2019to 3 Aug 2023
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai Hospital
New York, New York, 10029

Other trials in United States

About this study

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.

Read the detailed description

Protocol:

After receiving approval for the study, the researchers will conduct a prospective single institution randomized clinical trial assessing if using a TAP block perioperatively can reduce pain scores after surgery. Other endpoints include whether there are differences in pain medication usage and complications.

Patients will be screened by research team members and attending surgeons. If the patient is interested, the researchers will consent the participants for the study after understanding the study details, procedures, and expectations. The researchers will then consent using IRB approved study consent forms and procedures. Patients will undergo a laparoscopic inguinal hernia repair according to standard procedures. The study will assess if a TAP block impacts pain scores. Patients will be randomized to receive the intervention or placebo. Sequentially numbered sealed opaque envelopes with group allocation inside will alert the anesthesiologist \& surgeon to order Tap block composed of 0.25% bupivacaine or placebo (normal saline).

Inguinal hernia repair will be performed in standard fashion that each individual surgeon is familiar with. No additional tests or blood work outside the standard of care for IHR will be performed for research purposes. In addition, some patients will be given TAP blocks before surgery to help in pain management. Patients will be discharged with a worksheet on which the participants are to record analgesic use and pain scores on postoperative days one, two, three and four. The participants are expected to bring the completed log to their two-week follow up visit with their surgeon. Patients may also expect to receive a phone call from a member of the surgical team to remind them to record these metrics.

The TAP block is done pre-procedure using 0.25% bupivacaine. If patients weigh<100 kg, the patients will receive a total of 50 ml (25 ml on each side of the abdominal wall). If patients weigh>100 kg, the patients will receive a total of 60 ml (30ml on each side of the abdominal wall). The TAP plane is identified using ultrasound. All anesthesiologists (not surgeons) working with the attendings involved in this study have been trained in this technique; it is a routine part of their practice. It is anesthesiologists who will be performing the block.

Patients will be discharged with a worksheet /survey on which the patients are to record analgesic use and pain scores on postoperative days one, two, three and four. The patients are expected to bring the completed log to their two-week follow up visit.

Conditions: Inguinal Hernia
Being tested: 0.25% Bupivacaine, Placebo, TAP block
Medical subject headings: Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.25% BupivacaineDrug
received during TAP block
PlaceboDrug
placebo equivalent
TAP blockProcedure or surgery
The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).

Study groups in NCT05672680
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo; Procedure: TAP block
Experimental	Experimental	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. Receives: Drug: 0.25% Bupivacaine; Procedure: TAP block

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Score at Rest
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.
Measured: on post-op days 1, 2, 3, and 4
Pain Score at Rest
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.
Measured: All post-op (average 4 days)
Pain Score at Movement
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.
Measured: on post-op days 1, 2, 3, and 4
Pain Score at Movement
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.
Measured: All post-op (average 4 days)

Secondary outcomes (10)

Number of Opioid Pills
Patients recorded the number of opioid pills taken.
Measured: on post-op days 1, 2, 3, and 4
Number of Opioid Pills
Patients recorded the number of opioid pills taken.
Measured: All post-op (average 4 days)
Number of Non-opioid Pain Medication
Patients recorded the number of non-opioid pills taken for pain control.
Measured: on post-op days 1, 2, 3, and 4
Number of Non-opioid Pain Medication
Patients recorded the number of non-opioid pills taken for pain control.
Measured: All post-op (average 4 days)
Number of Intraoperative Complications
Chart review complications recorded. These are considered expected intraoperative complications and are not considered as adverse events based on research procedures.
Measured: up to 2 weeks post-surgery
Number of Participants With Contents in the Hernia
Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder.
Measured: during procedure
Number of Surgical Tacks Used Per Repair
Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain.
Measured: during procedure
Procedure Time
Procedure duration in minutes.
Measured: during procedure
Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss
Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure.
Measured: during procedure
Number of Patients Per Anesthesiologist
The number of patients handled per anesthesiologist.
Measured: during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20193 Aug 2023

First posted5 Jan 2023
Study start9 Dec 2019
Primary completion3 Aug 2023
Study completion3 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Inguinal HerniaStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05672680
Sponsor's protocol ID: STUDY-19-00677
Status last verified: Mar 2025
First submitted: 3 Jan 2023
Last updated: 28 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared. Data will be published in aggregate form without any PHI or references to the patient so as to keep identifying information secure.

Publications

Agathis AZ, Mathney ER, Higgins MS, Tufts LS, Wu JZ, Sherwin M, Zhang LP, Divino CM. Do transversus abdominis plane (TAP) blocks improve pain after laparoscopic bilateral inguinal hernia repairs beyond the recovery unit? A randomized control trial. Hernia. 2025 Jan 11;29(1):66. doi: 10.1007/s10029-025-03261-7.
PubMed 39798031

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
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Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
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Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
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Effect of Anterior Iliac Block on Postoperative Analgesia and Patient Satisfaction in Inguinal Hernia Repair Surgery
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All Inguinal Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
ClinicalTrials.gov ID: NCT05672680
Acronym / sponsor ID: STUDY-19-00677
Conditions: Inguinal Hernia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Study start: 9 Dec 2019 (actual)
Primary completion: 3 Aug 2023 (actual)
Study completion: 3 Aug 2023 (actual)
First posted: 5 Jan 2023 (actual)
Results: Posted 28 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Protocol:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Procedure: TAP blockNormal 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.
Experimental	Experimental	Drug: 0.25% Bupivacaine, Procedure: TAP block0.25% 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.25% Bupivacainereceived during TAP block	Drug	Experimental
Placeboplacebo equivalent	Drug	Placebo
TAP blockThe intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Procedure or surgery	Experimental, Placebo

Primary outcome

Pain Score at Rest
Time frame: 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.
Pain Score at Rest
Time frame: 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.
Pain Score at Movement
Time frame: 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.
Pain Score at Movement
Time frame: 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.

10 secondary outcomes

Number of Opioid Pills
Time frame: on post-op days 1, 2, 3, and 4
Number of Opioid Pills
Time frame: All post-op (average 4 days)
Number of Non-opioid Pain Medication
Time frame: on post-op days 1, 2, 3, and 4
Number of Non-opioid Pain Medication
Time frame: All post-op (average 4 days)
Number of Intraoperative Complications
Time frame: up to 2 weeks post-surgery
Number of Participants With Contents in the Hernia
Time frame: during procedure
Number of Surgical Tacks Used Per Repair
Time frame: during procedure
Procedure Time
Time frame: during procedure
Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss
Time frame: during procedure
Number of Patients Per Anesthesiologist
Time frame: during procedure

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	50	44
Experimental	50	46

Primary outcome: Pain Score at Rest

Time frame: on post-op days 1, 2, 3, and 4. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 44	Experimental n = 46
post-op day 1	4.31 (2.46)	4.55 (2.70)
post-op day 2	4.21 (2.49)	4.53 (2.61)
post-op day 3	3.53 (2.39)	3.77 (2.49)
post-op day 4	2.92 (2.39)	3.19 (2.46)

Primary outcome: Pain Score at Rest

Time frame: All post-op (average 4 days). Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 44	Experimental n = 46
Value	3.75 (2.48)	4.01 (2.65)

Primary outcome: Pain Score at Movement

Time frame: on post-op days 1, 2, 3, and 4. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 44	Experimental n = 46
post-op day 1	5.84 (2.42)	6.35 (2.54)
post-op day 2	5.47 (2.56)	6.16 (2.55)
post-op day 3	4.65 (2.21)	4.99 (2.51)
post-op day 4	3.71 (2.37)	4.31 (2.53)

Primary outcome: Pain Score at Movement

Time frame: All post-op (average 4 days). Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 44	Experimental n = 46
Value	4.93 (2.51)	5.46 (2.67)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 2 weeks post-surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Experimental	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Limitations and caveats (from the sponsor): Demographic information, like race and ethnicity was not obtained.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39798031Agathis AZ, Mathney ER, Higgins MS, Tufts LS, Wu JZ, Sherwin M, Zhang LP, Divino CM. Do transversus abdominis plane (TAP) blocks improve pain after laparoscopic bilateral inguinal hernia repairs beyond the recovery unit? A randomized control trial. Hernia. 2025 Jan 11;29(1):66. doi: 10.1007/s10029-025-03261-7.
Individual participant dataSharing planned: No. Individual participant data will not be shared. Data will be published in aggregate form without any PHI or references to the patient so as to keep identifying information secure.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Celia M Divino, MD principal investigator

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 0.25% Bupivacaine and TAP block in people with Inguinal Hernia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score at Rest (time frame: on post-op days 1, 2, 3, and 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672680, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.