Clinical trial NCT05177991: 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Inguinal Hernia
Ventral Hernia
Lead sponsor: Our Lady of the Lake Hospital
Sponsor class: OTHER
Collaborators: name: Our Lady of the Lake Hospital
First posted: 2022-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blind, randomized
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Subjective Pain Scores using Visual Analog Scale (VAS)
timeFrame: For 1 week post-operation
Secondary outcomes:
measure: Opioids Used Post-Operatively compared in anesthesia arms
timeFrame: For 1 Week post-operation
measure: Opioids Used Post-Operatively related to Hernia Size and Surgical Time
timeFrame: After 1 week post-operation
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Karl LeBlanc
state: Louisiana
Study officials:
affiliation: Our Lady of the Lake Hospital
name: Leslie Son, PhD
role: STUDY_DIRECTOR
References: