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Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.25% Bupivacaine
Placebo
TAP block
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Experimental

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Score
On the "pain score" instrument, patients will score their pain score at rest and on movement. The full scale is score between 1-10, with higher score indicating more pain.

Secondary Outcome Measures

Number of opioid pills
Patients will record the number of opioid pills taken.
Number of non-opioid pain medication
Patients will record the number of non-opioid pills taken for pain control.
Number of Complications
Through chart review, complications (morbidity and mortality) will be recorded.

Full Information

First Posted
January 3, 2023
Last Updated
October 17, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05672680
Brief Title
Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
Official Title
Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
August 3, 2023 (Actual)
Study Completion Date
August 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.25% Bupivacaine
Intervention Description
received during TAP block
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo equivalent
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
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 Outcome Measure Information:
Title
Pain Score
Description
On the "pain score" instrument, patients will score their pain score at rest and on movement. The full scale is score between 1-10, with higher score indicating more pain.
Time Frame
on post-op days 1-4
Secondary Outcome Measure Information:
Title
Number of opioid pills
Description
Patients will record the number of opioid pills taken.
Time Frame
on post-op days 1-4
Title
Number of non-opioid pain medication
Description
Patients will record the number of non-opioid pills taken for pain control.
Time Frame
on post-op days 1-4
Title
Number of Complications
Description
Through chart review, complications (morbidity and mortality) will be recorded.
Time Frame
up to 2 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia M Divino, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

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