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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03927326

Recruitment Status Not yet recruiting

First Posted April 25, 2019

Last update posted April 25, 2019

Study Description

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:Pain, Postoperative
    Anesthesia, Local
    Anesthesia; Functional
    Anesthesia
    Opioid Use
  • Intervention/Treatment: Drug: Exparel 266 MG Per 20 ML Injection
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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
Arms and interventions
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
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

Contact: Alan Chang, MD 714-878-0850 achang5@uw.edu

Locations
Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator: Vanessa Loland, MD University of Washington

More Information