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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: Completed Phase 4 study of Colorectal Disorders, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.
Conditions Studied
Interventions
- DRUG Exparel
- DRUG IV Lidocaine
Study Locations (1)
North Carolina
- Atrium Health - Carolinas Medical Center - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2021-07-20 |
| Phase | Phase 4 |
What the finished NCT04005859 record still lists
NCT04005859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 406-participant average among 7 other Colorectal Disorders trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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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