Exparel Use in Bilateral TAP Blocks for Postoperative Pain Control



Status:Recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:January 15, 2019
End Date:January 14, 2020
Contact:Anna Ng Pellegrino, MD
Email:anna.ngpellegrino@sluhn.org
Phone:610-954-5819

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The Use of Exparel (Liposomal Bupivacaine) for Bilateral TAP (Transversus Abdominis Plane) Blocks in Open Abdomen Surgery for Postoperative Pain Control

To determine if Exparel (Liposomal Bupivacaine, an FDA approved drug) use in ultrasound
guided Transversus Abdominis Plane (TAP) blocks may reduce opioid requirement use
postoperatively, reduce pain scores postoperatively, reduce incidence of nausea in the postop
period, and decrease length of hospital stay

Exparel is liposomal form of bupivacaine, a local anesthetic. Secondary to its liposomal
nature, Exparel slowly releases bupivacaine into the area injected (ultrasound guided field
block) so that it may provide relief from pain for up to 48-72 hours time.

Exparel in TAP blocks may be performed on patients undergoing open or laparoscopic hand
assisted abdomen/pelvic procedures, who are NOT candidates for an epidural (anticoagulation
medication use, history of spine surgery with metal hardware of the mid-lower back) or as a
rescue block for patients who undergo laparoscopic surgery but converted to open abdominal
surgery in the operating room.

This block is usually performed intraoperatively (before patient wakes up from anesthesia) or
in the immediate postop recovery unit (PACU) area.

Anesthesia personnel who have been well trained to perform ultrasound guided bilateral TAP
blocks will combine Exparel 20 cc's with 0.25% Bupivicaine 20 ccs and 20 ccs of normal saline
into a 60 cc syringe. With ultrasound machine, they will locate the TAP block on each side of
abdomen with a Stimuplex needle. Once the TAP area is found, hydrodissection with normal
saline is used to confirm TAP area, and then 30 ccs of the Exparel/0.25% Bupivacaine/normal
saline solution administered to each side.

Patients are seen in the PACU area, where pain scores and oral morphine equivalents (OME) are
calculated. Patient seen in postoperative day (POD) 1 to discuss expectations of pain control
and goals for pain management (i.e. use of multimodal pain regimen and goals to decrease
opioid use). A flyer (approved by the Patient Education Committee) is provided to patient on
POD 1 for further patient education. Pain scores and OMEs calculated for POD 0-5. Progress
notes in patient's chart and patient interview also discloses if patient had episodes of N/V,
another data point we will collect. We will finally review patient charts for length of
admission (date of admission to date of discharge) Our control group: patients that had open
abdominal or hand assisted laparoscopic surgery and who did not receive a TAP block, and
received mainly opioids for postop pain control. For the comparison (control) group, we will
calculate OME requirements while in PACU, and from POD 1-POD 5. We will see patients during
POD 1 to discuss expectations of pain control and goals for pain management. Progress notes
in patient's chart and patient interview also discloses if patient had episodes of N/V,
another data point we will collect. We will finally review patient's chart for length of
admission (date of admission to date of discharge) We are looking for an N=20 for the Exparel
TAP block (experimental) group and N=20 for no TAP block (control) group

Inclusion Criteria:

- Women of Reproductive Potential

- Men of Reproductive Potential

- Minorities

- Healthy Controls/Volunteers

- Employees/Students

- Vulnerable populations (trauma victims, students > 18 yrs age, aged infirm, substance
abusers, impoverished, terminally ill,)

patients of above inclusion criteria who 1) are not candidates of an neuraxial blockade
(i.e. epidural) for postoperative pain control 2) who underwent a laparoscopic to open
procedure intraoperatively

Exclusion Criteria:

- advanced dementia, not oriented to time or place

- advanced liver disease

- pregnant patients

- allergy to amide local anesthesia

- allergy to methemoglobinemia
We found this trial at
1
site
Bethlehem, Pennsylvania 18017
Phone: 610-954-5810
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Bethlehem, PA
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