Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Pain, Postoperative, Delirium, Anesthesia, Local
In brief
A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores. This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.
Key facts
- Study ID
- NCT03149783
- Run by
- University of Colorado, Denver
- People needed
- 80
- Starts
- 2018-02-13
- Expected to finish
- 2021-10-31
- Last updated by the study team
- 2021-05-27
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >=50 years.
- Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery.
You may not qualify if…
- Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable.
- Patients with an epidural or spinal catheter block.
- Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion.
- Patients who are abusing alcohol defined by a high AUDIT score (>8) will be excluded.
- History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia).
- Patients with a documented allergy to ropivacaine or other sodium channel blockers.
Where it is running
- Denver Veterans Affairs Medical Center — Denver, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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