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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

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

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.

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 groupRoleWhat they receive
PlaceboPlacebo comparatorNormal 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
ExperimentalExperimental0.25% 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.

  1. 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

  2. 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)

  3. 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

  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)
  1. Number of Opioid Pills

    Patients recorded the number of opioid pills taken.

    Measured: on post-op days 1, 2, 3, and 4

  2. Number of Opioid Pills

    Patients recorded the number of opioid pills taken.

    Measured: All post-op (average 4 days)

  3. 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

  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)

  5. 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

  6. 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

  7. 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

  8. Procedure Time

    Procedure duration in minutes.

    Measured: during procedure

  9. 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

  10. 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.

  1. First posted5 Jan 2023
  2. Study start9 Dec 2019
  3. Primary completion3 Aug 2023
  4. Study completion3 Aug 2023

Resources

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
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

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