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Completed

NCT Number: NCT05672680

Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mount Sinai Hospital

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.25% Bupivacaine

Drug

received during TAP block

Placebo

Drug

placebo equivalent

TAP Block

Procedure

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.).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Number of Opioid Pills

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

    Patients recorded the number of opioid pills taken.

  2. Number of Opioid Pills

    Time frame: All post-op (average 4 days)

    Patients recorded the number of opioid pills taken.

  3. Number of Non-opioid Pain Medication

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

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

  4. Number of Non-opioid Pain Medication

    Time frame: All post-op (average 4 days)

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

  5. Number of Intraoperative Complications

    Time frame: 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.

  6. Number of Participants With Contents in the Hernia

    Time frame: during procedure

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

  7. Number of Surgical Tacks Used Per Repair

    Time frame: during procedure

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

  8. Procedure Time

    Time frame: during procedure

    Procedure duration in minutes.

  9. Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss

    Time frame: during procedure

    Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure.

  10. Number of Patients Per Anesthesiologist

    Time frame: during procedure

    The number of patients handled per anesthesiologist.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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