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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Drug: Placebo; Procedure: TAP block; Drug: 0.25% Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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.	Drug: Placebo; placebo equivalent; Procedure: TAP block; 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.).
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.	Procedure: TAP block; 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.).; Drug: 0.25% Bupivacaine; received during TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	All post-op (average 4 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Opioid Pills	Patients recorded the number of opioid pills taken.	on post-op days 1, 2, 3, and 4
Number of Opioid Pills	Patients recorded the number of opioid pills taken.	All post-op (average 4 days)
Number of Non-opioid Pain Medication	Patients recorded the number of non-opioid pills taken for pain control.	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.	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.	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.	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.	during procedure
Procedure Time	Procedure duration in minutes.	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.	during procedure
Number of Patients Per Anesthesiologist	The number of patients handled per anesthesiologist.	during procedure

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Celia M Divino, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: STUDY-19-00677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No