Phase 4
N=61
Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Colorectal Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04005859 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Verbal Pain Scale (VRS) - 4 Week Post-op — 0.4; 1.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exparel (Drug); IV Lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal Pain Scale (VRS) - 4 Week Post-op |
0.4; 1.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-75 years
- Elective laparoscopic colorectal surgery
- ASA I-III
Exclusion Criteria
- Contraindication to Na Channel Blocker
- Chronic Opioid use
- Liver dysfunction
- Renal insufficiency
- Epilepsy
- Psychomotor retardation
- BMI >40
- Sleep Apnea
- Cardiac Rhythm Disorders
- Planned open or concomitant procedure
Data sourced from ClinicalTrials.gov (NCT04005859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.