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.

Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs

Inguinal Hernia

Ventral Hernia

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.

Liposomal Bupivacaine

Bupivacaine

The Evaluation of Post-operative Pain Control With a TAP Block Using Exparel vs. Marcaine for Hernia Repairs

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.

Research Scientist

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.

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.

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.

Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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