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Exparel Use in Bilateral TAP Blocks for Postoperative Pain Control

Primary Purpose

Postoperative Pain, Surgery, Anesthesia, Local

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel 266 MG Per 20 ML Injection
Sponsored by
St. Luke's Hospital, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring liposomal bupivacaine, TAP block, pain control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Luke's University Hospital Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exparel use in TAP block

no TAP block

Arm Description

Exparel used in bilateral TAP block for open abdomen surgery

these patients, N=20, did not received a bilateral TAP block for postoperative pain control. Instead, pain control involves PO/IV pain medications

Outcomes

Primary Outcome Measures

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
Reduce pain scores after surgery
Numerical Rating Scale: 0-10; 0 being no pain, 10 being worst pain imaginable possible

Secondary Outcome Measures

Reduce incidence of nausea postoperatively
will review in daily progress notes incidence of nausea
Decrease length of hospital stay
will review patient's admission encounter in chart and see when patient is discharged

Full Information

First Posted
March 9, 2019
Last Updated
December 16, 2020
Sponsor
St. Luke's Hospital, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03878888
Brief Title
Exparel Use in Bilateral TAP Blocks for Postoperative Pain Control
Official Title
The Use of Exparel (Liposomal Bupivacaine) for Bilateral TAP (Transversus Abdominis Plane) Blocks in Open Abdomen Surgery for Postoperative Pain Control
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's Hospital, Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Surgery, Anesthesia, Local
Keywords
liposomal bupivacaine, TAP block, pain control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Masking Description
no masking; will provide qualified patients the opportunity to receive Exparel (liposomal bupivacaine) in Bilateral TAP blocks for open abdomen surgery
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exparel use in TAP block
Arm Type
Experimental
Arm Description
Exparel used in bilateral TAP block for open abdomen surgery
Arm Title
no TAP block
Arm Type
No Intervention
Arm Description
these patients, N=20, did not received a bilateral TAP block for postoperative pain control. Instead, pain control involves PO/IV pain medications
Intervention Type
Drug
Intervention Name(s)
Exparel 266 MG Per 20 ML Injection
Other Intervention Name(s)
liposomal bupivacaine
Intervention Description
patients receive Exparel in bilateral TAP blocks for open abdomen surgery
Primary Outcome Measure Information:
Title
Reduce opioid requirement use (calculated oral morphine equivalents (OME)) for 2-3 days time after surgery.
Description
will review opioid/narcotic use in patient's chart
Time Frame
up until postoperative day 5
Title
Reduce pain scores after surgery
Description
Numerical Rating Scale: 0-10; 0 being no pain, 10 being worst pain imaginable possible
Time Frame
up until postoperative day 5
Secondary Outcome Measure Information:
Title
Reduce incidence of nausea postoperatively
Description
will review in daily progress notes incidence of nausea
Time Frame
up until Postoperative day 5
Title
Decrease length of hospital stay
Description
will review patient's admission encounter in chart and see when patient is discharged
Time Frame
up until postoperative day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Ng Pellegrino, MD
Organizational Affiliation
St. Luke's University Health Network - Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's University Hospital Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28852531
Citation
Seagle BL, Miller ES, Strohl AE, Hoekstra A, Shahabi S. Transversus abdominis plane block with liposomal bupivacaine compared to oral opioids alone for acute postoperative pain after laparoscopic hysterectomy for early endometrial cancer: a cost-effectiveness analysis. Gynecol Oncol Res Pract. 2017 Aug 22;4:12. doi: 10.1186/s40661-017-0048-7. eCollection 2017.
Results Reference
background
PubMed Identifier
27156796
Citation
Fayezizadeh M, Majumder A, Neupane R, Elliott HL, Novitsky YW. Efficacy of transversus abdominis plane block with liposomal bupivacaine during open abdominal wall reconstruction. Am J Surg. 2016 Sep;212(3):399-405. doi: 10.1016/j.amjsurg.2015.12.026. Epub 2016 Apr 12.
Results Reference
result
PubMed Identifier
25170277
Citation
Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.
Results Reference
result
PubMed Identifier
22067185
Citation
Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
Results Reference
result
Links:
URL
http://clinicaltrials.gov
Description
Ching, Heidi. A comparison of Exparel to Bupivacaine in TAP block for Abdominal Gynecologic surgery. clinicaltrials.gov : NCT03304444.
URL
http://clinicaltrials.gov
Description
Turan Et. Al. Bilateral Transversus Abdominis Plane Block with Exparel vs. Continuous Epidural Analgesia with Bupivacaine. Clinical trials.gov: NCT02996227

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Exparel Use in Bilateral TAP Blocks for Postoperative Pain Control

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