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Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision

NCT03870685 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-07-14

No results posted yet for this study

Summary

This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to compare postoperative opioid consumption and pain scores of patients with suspected or known gynecologic malignancies undergoing midline laparotomy who received TAP block with liposomal bupivacaine versus surgical site infiltration of liposomal bupivacaine.

Primary outcome: Total postoperative opioid consumption as measured by morphine equivalents over 48 hour period.

Secondary outcomes include: Pain scores (based on visual analog scale 1-10) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively at rest and upon exertion (Valsalva maneuver), Severity of nausea, Episodes of vomiting, Total antiemetics consumption over 48 hour period.

Conditions

  • Postoperative Pain
  • Postoperative Nausea and Vomiting
  • Opioid Use

Interventions

PROCEDURE

TAP Block

Transversus Plane block

PROCEDURE

Surgical Site Infiltration

Surgical Site Infiltration

DRUG

Exparel

liposomal bupivacaine

Sponsors & Collaborators

  • Danbury Hospital

    lead OTHER

Principal Investigators

  • Linus Chuang, MD · Danbury Hospital, Nuvance Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2021-02-15
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870685 on ClinicalTrials.gov