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

Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration

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: NCT03927326
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Alan Chang, University of Washington

Brief Summary:
This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Anesthesia, Local Anesthesia; Functional Anesthesia Opioid Use Drug: Exparel 266 MG Per 20 ML Injection Not Applicable

Detailed Description:

Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.

A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Unblinded randomized trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: On Postoperative Analgesic Requirements in Laparoscopic Colorectal Surgery Patients After Exparel Administration Via Transversus Abdominis Plane Block Versus Surgical Infiltration
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Local infiltration
Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites.
Drug: Exparel 266 MG Per 20 ML Injection
Liposomal bupivacaine

Experimental: Transversus abdominis plane block
Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block.
Drug: Exparel 266 MG Per 20 ML Injection
Liposomal bupivacaine




Primary Outcome Measures :
  1. 24 hour post operative opioid consumption [ Time Frame: 24 hours postoperative ]
    Listed in morphine daily equivalents.


Secondary Outcome Measures :
  1. 12 hour post operative opioid consumption [ Time Frame: 12 hours postoperative ]
    Listed in morphine daily equivalents

  2. 48 hour post operative opioid consumption [ Time Frame: 48 hours postoperative ]
    Listed in morphine daily equivalents

  3. Pain intensity at 12 hours post operative [ Time Frame: 12 hours ]
    Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)

  4. Pain intensity at 24 hours post operative [ Time Frame: 24 hours ]
    Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)

  5. Hospital length of stay [ Time Frame: Until end of hospital stay, typically 3 days ]
    How long the patient requires their inpatient stay measured in days.



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 to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay

Exclusion Criteria:

  • Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents
  • Patients allergic to bupivacaine
  • Patients with ASA status IV, V, or VI
  • Patients unable to consent
  • Patients that are pregnant
  • Patients that are incarcerated
  • Patients receiving procedures in addition to laparoscopic colorectal procedure
  • Patients on systemic anticoagulation precluding them from regional blocks

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): NCT03927326


Contacts
Layout table for location contacts
Contact: Alan Chang, MD 714-878-0850 achang5@uw.edu

Sponsors and Collaborators
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Vanessa Loland, MD University of Washington
Publications:

Layout table for additonal information
Responsible Party: Alan Chang, Resident, School of Medicine: Anesthesiology and Pain Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03927326    
Other Study ID Numbers: STUDY00007182
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not planning on making IPD available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations