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Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
NCT04005859 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2021-07-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04005859
The ClinicalTrials.gov registry entry for NCT04005859 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04005859 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04005859?
The interventions under investigation include: Exparel (DRUG), IV Lidocaine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04005859?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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