Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

NCT05672680 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY-19-00677
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (10)

• Number of Opioid Pills

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

• Number of Opioid Pills

  All post-op (average 4 days)

• Number of Non-opioid Pain Medication

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

• Number of Non-opioid Pain Medication

  All post-op (average 4 days)

• Number of Intraoperative Complications

  up to 2 weeks post-surgery

Study Arms (2)

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.

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.

Drug: 0.25% Bupivacaine; Procedure: TAP block

Interventions

0.25% Bupivacaine DRUG

received during TAP block

Experimental

Placebo DRUG

placebo equivalent

Placebo

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.).

Experimental; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Demographic information, like race and ethnicity was not obtained.

Results Point of Contact

• Title: Celia Divino
• Organization: Icahn School of Medicine at Mount Sinai

celia.divino@mountsinai.org

(212) 241-3348

Study Officials

• Celia M Divino, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Edelman Professor of Surgery

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: December 9, 2019
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)