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NCT04005859 · ClinicalTrials.gov registry record · Phase 4

Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane

A Phase 4 study of Colorectal Disorders, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 4
Development phase
61
Enrollment target
1
Study location

NCT04005859 is a Phase 4 study of Colorectal Disorders that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 61 participants, below the 406-participant average among 7 other Colorectal Disorders trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04005859, a Phase 4 study of Colorectal Disorders, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 4
Development phase
61 participants
Enrollment target
1
Study location

Study Summary

To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.

Conditions Studied

Interventions

  • DRUG Exparel
  • DRUG IV Lidocaine

Study Locations (1)

North Carolina

  • Atrium Health - Carolinas Medical Center - Charlotte

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2018-02-22
Est. Completion 2021-07-20
Phase Phase 4

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT04005859

The ClinicalTrials.gov registry entry for NCT04005859 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 406-participant average among 7 other Colorectal Disorders trials with a reported enrollment target (85% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Disorders appearing as the primary indexed condition, and to 2 interventions - of which Exparel is the first listed.

NCT04005859 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT04005859 about?

NCT04005859 is a clinical study titled "Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane". To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pa...

What is the current status of trial NCT04005859?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2018-02-22. Estimated completion is 2021-07-20.

What conditions does trial NCT04005859 study?

This clinical trial studies the following conditions: Colorectal Disorders.

What interventions are being tested in trial NCT04005859?

The interventions under investigation include: Exparel (DRUG), IV Lidocaine (DRUG).

Who is sponsoring clinical trial NCT04005859?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04005859 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.