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Exparel Use in Bilateral TAP Blocks for Postoperative Pain Control

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03878888
Enrollment
52
Registered
2019-03-18
Start date
2019-01-15
Completion date
2019-07-01
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Postoperative Pain, Surgery

Keywords

liposomal bupivacaine, TAP block, pain control

Brief summary

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

Detailed description

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

Interventions

patients receive Exparel in bilateral TAP blocks for open abdomen surgery

Sponsors

St. Luke's Hospital, Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

no masking; will provide qualified patients the opportunity to receive Exparel (liposomal bupivacaine) in Bilateral TAP blocks for open abdomen surgery

Intervention model description

experimental group: patients having open abdominal surgery that will receive a bilateral TAP block with Exparel control group: patients having open abdominal surgery that will not receive a bilateral TAP block with Exparel

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reduce opioid requirement use (calculated oral morphine equivalents (OME)) for 2-3 days time after surgery.up until postoperative day 5will review opioid/narcotic use in patient's chart
Reduce pain scores after surgeryup until postoperative day 5Numerical Rating Scale: 0-10; 0 being no pain, 10 being worst pain imaginable possible

Secondary

MeasureTime frameDescription
Reduce incidence of nausea postoperativelyup until Postoperative day 5will review in daily progress notes incidence of nausea
Decrease length of hospital stayup until postoperative day 5will review patient's admission encounter in chart and see when patient is discharged

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026