Adults 18 to 75, any sex, with Colorectal Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Verbal Pain Scale (VRS) - 4 Week Post-opPrimary· Single VRS assessed at 4-week post-op visit (or phone call)
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.
Group
Value
95% CI
CONTROL: IV Lido
0.4
± 0.7
EXPERIMENTAL: Exparel
1.1
± 2.0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 9 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04005859.