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

Not Applicable

• Conditions: Opioid Use; Anesthesia; Functional; Anesthesia; Pain, Postoperative; Anesthesia, Local
• Interventions: Drug: Exparel 266 MG Per 20 ML Injection

• Registration Number: NCT03927326
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Study First Posted: 2019-04-25
• Last Update Posted: 2019-04-25
• Study Start: 2019-08
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local infiltration	Exparel 266 MG Per 20 ML Injection	Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites.
Transversus abdominis plane block	Exparel 266 MG Per 20 ML Injection	Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block.

Primary Outcome Measures

Name	Time	Method
24 hour post operative opioid consumption	24 hours postoperative	Listed in morphine daily equivalents.

Secondary Outcome Measures

Name	Time	Method
12 hour post operative opioid consumption	12 hours postoperative	Listed in morphine daily equivalents
Pain intensity at 12 hours post operative	12 hours	Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
48 hour post operative opioid consumption	48 hours postoperative	Listed in morphine daily equivalents
Pain intensity at 24 hours post operative	24 hours	Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
Hospital length of stay	Until end of hospital stay, typically 3 days	How long the patient requires their inpatient stay measured in days.