Paravertebral Block Versus No Block in Open Pancreaticoduodenectomy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-012297
NCT ID: NCT05820997
About this study
The purporse of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study we would plan to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients willing and have signed consent.
- Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB).
Exclusion Criteria:
- Not able or unwilling to sign consent.
- Currently pregnant or lactating.
- Patients with chronic pain, requiring daily opiate use at time of surgery.
- Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/22/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator John Stauffer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available