Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exparel Use in Bilateral TAP Blocks for Postoperative Pain Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03878888
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
St. Luke's Hospital, Pennsylvania

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Surgery Anesthesia, Local Drug: Exparel 266 MG Per 20 ML Injection Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
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
Primary Purpose: Treatment
Official Title: The Use of Exparel (Liposomal Bupivacaine) for Bilateral TAP (Transversus Abdominis Plane) Blocks in Open Abdomen Surgery for Postoperative Pain Control
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 14, 2020
Estimated Study Completion Date : January 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exparel use in TAP block
Exparel used in bilateral TAP block for open abdomen surgery
Drug: Exparel 266 MG Per 20 ML Injection
patients receive Exparel in bilateral TAP blocks for open abdomen surgery
Other Name: liposomal bupivacaine

No Intervention: no TAP block
these patients, N=20, did not received a bilateral TAP block for postoperative pain control. Instead, pain control involves PO/IV pain medications



Primary Outcome Measures :
  1. Reduce opioid requirement use (calculated oral morphine equivalents (OME)) for 2-3 days time after surgery. [ Time Frame: up until postoperative day 5 ]
    will review opioid/narcotic use in patient's chart

  2. Reduce pain scores after surgery [ Time Frame: up until postoperative day 5 ]
    Numerical Rating Scale: 0-10; 0 being no pain, 10 being worst pain imaginable possible


Secondary Outcome Measures :
  1. Reduce incidence of nausea postoperatively [ Time Frame: up until Postoperative day 5 ]
    will review in daily progress notes incidence of nausea

  2. Decrease length of hospital stay [ Time Frame: up until postoperative day 5 ]
    will review patient's admission encounter in chart and see when patient is discharged



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878888


Contacts
Layout table for location contacts
Contact: Anna Ng Pellegrino, MD 610-954-5819 anna.ngpellegrino@sluhn.org
Contact: Jayne Silva 484-526-6742

Locations
Layout table for location information
United States, Pennsylvania
St. Luke's University Hospital Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Anna Ng Pellegrino, MD    610-954-5810    anna.ngpellegrino@sluhn.org   
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Anna Ng Pellegrino, MD St. Luke's University Health Network - Anesthesia
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier: NCT03878888    
Other Study ID Numbers: stluke
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by St. Luke's Hospital, Pennsylvania:
liposomal bupivacaine
TAP block
pain control
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents