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.
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celia M. Divino, Icahn School of Medicine at Mount Sinai
- Investigators
- Celia M Divino, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
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