A Phase 4 interventional study of Exparel 266 MG Per 20 ML Injection in Postoperative Pain, Surgery and Anesthesia, Local, sponsored by St. Luke's Hospital, Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by St. Luke's Hospital, Pennsylvania · Phase 4, Interventional, and Treatment
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
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 52 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →St. Luke's Hospital, Pennsylvania is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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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:
Exparel used in bilateral TAP block for open abdomen surgery
Drug: Exparel 266 MG Per 20 ML Injection
these patients, N=20, did not received a bilateral TAP block for postoperative pain control. Instead, pain control involves PO/IV pain medications
patients receive Exparel in bilateral TAP blocks for open abdomen surgery
Also known as: liposomal bupivacaine
Reduce opioid requirement use (calculated oral morphine equivalents (OME)) for 2-3 days time after surgery.
will review opioid/narcotic use in patient's chart
Time frame: up until postoperative day 5
Reduce pain scores after surgery
Numerical Rating Scale: 0-10; 0 being no pain, 10 being worst pain imaginable possible
Time frame: up until postoperative day 5
Reduce incidence of nausea postoperatively
will review in daily progress notes incidence of nausea
Time frame: up until Postoperative day 5
Decrease length of hospital stay
will review patient's admission encounter in chart and see when patient is discharged
Time frame: up until postoperative day 5
Plan to share: No
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St. Luke's Hospital, Pennsylvania