Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs
Primary Purpose
Inguinal Hernia, Ventral Hernia
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Have a ventral or inguinal hernia requiring surgical repair
Exclusion Criteria:
- Less than 18 years of age
- Chronic pain patients
- Having a defect >10 cm in transverse dimension
- Having a defect <4 cm
- Has an allergy to bupivacaine
- Has recurrent hernias as per medical history
- A TAP block performed at any time aside from just prior to the start of the procedure
- If bupivacaine is mixed with other anesthetics
- Under the instance of an emergency surgery (trauma)
- Concomitant surgery
- History of EtOH abuse
- History of liver/kidney dysfunction
- If the procedure must be converted to open
- Inidividual's weight < 50kg
- Individual's BMI > 45
Sites / Locations
- Karl LeBlancRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Liposomal Bupivacaine (Exparel)
Bupivacaine (Marcaine)
Arm Description
The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.
The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.
Outcomes
Primary Outcome Measures
Subjective Pain Scores using Visual Analog Scale (VAS)
Lower mean daily post-operative pain scores between participants in the Exparel vs. Bupivacaine arms recorded multiple times over the observation period. The pain scale is 0-10 with 0 being no pain to 10 being the worst pain possible.
Secondary Outcome Measures
Opioids Used Post-Operatively compared in anesthesia arms
The amount of opioid pills taken, as measured by morphine equivalents, is reduced depending on the type of anesthetic used during the TAP block. We will be measuring the post operative opioid usage by asking the patients how many narcotic pills they take daily after surgery for one week. Variability comes into play if we prescribe different doses of Norco or if we use Percocet, therefore we will standardize this by converting these differing dosages in to morphine equivalents for both groups.
Opioids Used Post-Operatively related to Hernia Size and Surgical Time
A decrease in the total number of opioid pills taken post-operatively compared to the total surgical time and how large the hernia defect is. Increased surgical times and larger hernias may play a role in the amount of pain medication an individual may need post-operatively.
Full Information
NCT ID
NCT05177991
First Posted
December 2, 2021
Last Updated
April 19, 2022
Sponsor
Leslie Son
Collaborators
Our Lady of the Lake Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05177991
Brief Title
Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs
Official Title
The Evaluation of Post-operative Pain Control With a TAP Block Using Exparel vs. Marcaine for Hernia Repairs
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leslie Son
Collaborators
Our Lady of the Lake Regional Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.
Detailed Description
Approximately 200 patients in the study will be randomized to one of two arms: TAP block with Exparel or TAP block with bupivacaine. Randomization will be performed using a permuted block randomization algorithm (Ex. AABBABABABBABBAA, where A=Exparel group and B=Bupivacaine group). Only the participant will be blinded to the arm assignment as the knowledge of the assignment for the surgeon and anesthesiologist is needed. The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites. Both of these anesthetics being evaluated and the dosage are commonly administered as standard of care (SOC). The choice of anesthetic used is up to the discretion of the surgeon in most instances. The patients will be blinded to which local anesthetic they receive. Operative technique will be standardized amongst all participating surgeons.
All patients with ventral hernias will undergo an IPOM+ technique detailed by primary closure of the defect in addition to circumferential mesh fixation with a running suture. Three or four trochars will be used ranging from 5-12mm in size. Mesh selection will be at the discretion of the surgeon with a minimum of 5cm overlap of the original defect in all directions. Defect size will be measured intraoperatively with a ruler intra-abdominally.
All patients with an inguinal hernia will undergo a transabdominal preperitoneal hernia repair with mesh placement. Three or four trochars ranging from 5-12mm will be used. Size of mesh and fixation of mesh at one or two points will be at the surgeon's discretion. The length of surgery will be recorded.
The patients will be given a packet of VAS pain assessments to take home with pre-marked time intervals to fill out at 2h, 6h, and 12h post operatively as well as every 12 hours thereafter. The patients will also be asked to record how many narcotic medications they will be consuming on a daily basis. Our team will contact patients daily to collect the data verbally which will also serve as a reminder to patients to complete this task faithfully. Each patient will follow up at one week and provide the surgeons with the packet of VAS assessments as well as bring in any excess narcotics that they did not consume. Each patient will also be told to take tylenol 500mg every 6 hours for the first 96 hours and to record whether they take any additional alternative pain medications (NSAIDs, muscle relaxants, gabapentinoids). Upon discharge, patients will be prescribed 15 pills of 5mg hydrocodone-325mg acetaminophen to be taken every 6 hours as needed for severe pain.
Data collection will include demographics of the patients including age, sex, ASA status, height/weight, BMI, preoperative pain level and previous abdominal surgeries. Intraoperative variables will include defect size, ventral vs. inguinal, number of trochar, mesh size and type, operative time. Postoperative collection will include pain scores as outlined above and narcotic use. Data analysis will include differences, if any, in post operative pain scores as well as narcotic use. This will be stratified to the inguinal hernia group vs. ventral hernias and the ventral hernia group will be stratified to size of defect and length of surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Ventral Hernia
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Single Blind, randomized
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine (Exparel)
Arm Type
Active Comparator
Arm Description
The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.
Arm Title
Bupivacaine (Marcaine)
Arm Type
Active Comparator
Arm Description
The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
20cc of Liposomal Bupivacaine for TAP block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
20cc of Bupivacaine for TAP block
Primary Outcome Measure Information:
Title
Subjective Pain Scores using Visual Analog Scale (VAS)
Description
Lower mean daily post-operative pain scores between participants in the Exparel vs. Bupivacaine arms recorded multiple times over the observation period. The pain scale is 0-10 with 0 being no pain to 10 being the worst pain possible.
Time Frame
For 1 week post-operation
Secondary Outcome Measure Information:
Title
Opioids Used Post-Operatively compared in anesthesia arms
Description
The amount of opioid pills taken, as measured by morphine equivalents, is reduced depending on the type of anesthetic used during the TAP block. We will be measuring the post operative opioid usage by asking the patients how many narcotic pills they take daily after surgery for one week. Variability comes into play if we prescribe different doses of Norco or if we use Percocet, therefore we will standardize this by converting these differing dosages in to morphine equivalents for both groups.
Time Frame
For 1 Week post-operation
Title
Opioids Used Post-Operatively related to Hernia Size and Surgical Time
Description
A decrease in the total number of opioid pills taken post-operatively compared to the total surgical time and how large the hernia defect is. Increased surgical times and larger hernias may play a role in the amount of pain medication an individual may need post-operatively.
Time Frame
After 1 week post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Have a ventral or inguinal hernia requiring surgical repair
Exclusion Criteria:
Less than 18 years of age
Chronic pain patients
Having a defect >10 cm in transverse dimension
Having a defect <4 cm
Has an allergy to bupivacaine
Has recurrent hernias as per medical history
A TAP block performed at any time aside from just prior to the start of the procedure
If bupivacaine is mixed with other anesthetics
Under the instance of an emergency surgery (trauma)
Concomitant surgery
History of EtOH abuse
History of liver/kidney dysfunction
If the procedure must be converted to open
Inidividual's weight < 50kg
Individual's BMI > 45
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine LeBoeuf, DNP
Phone
225-765-5956
Email
Christine.LeBoeuf@fmolhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Tomkins, MS
Phone
225-765-7979
Email
jill.tomkins@fmolhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Son, PhD
Organizational Affiliation
Our Lady of the Lake Regional Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Karl LeBlanc
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl LeBlanc, MD
Phone
225-769-5656
Email
karl.leblanc@fmolhs.org
First Name & Middle Initial & Last Name & Degree
Love Vimal, MD
Phone
225-769-5656
Email
love.vimal@fmolhs.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs
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