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Paravertebral Block for Pancreatic Surgery
Phase 4
Recruiting
Led By John Stauffer, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 48 hours after surgery
Awards & highlights
Study Summary
This trial will compare pain control during & after open pancreatic surgery. Data will be recorded for length of stay & complications to improve patient outcomes.
Who is the study for?
This trial is for nonpregnant adults who are about to have open pancreaticoduodenectomy surgery and can give consent. It's not for those with chronic pain on daily opiates, opiate intolerance, or allergies to pain meds like NSAIDs, acetaminophen, or local anesthetics.Check my eligibility
What is being tested?
The study compares the effectiveness of a Paravertebral block (PVB) using Ropivacaine versus no block in managing pain during and after pancreaticoduodenectomy. The length of hospital stay and complications will also be tracked.See study design
What are the potential side effects?
Possible side effects from Ropivacaine may include nausea, low blood pressure, allergic reactions, nerve damage or infection at the injection site but these vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult not pregnant and can have a surgery on my pancreas with a specific pain block.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 48 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 48 hours after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean post-operative pain score
Secondary outcome measures
Hospital Length of Stay
Number of subjects with a bowel obstruction
Trial Design
2Treatment groups
Active Control
Group I: Paravertebral Block Pre ProcedureActive Control1 Intervention
Subject will receive a preoperative paravertebral block only
Group II: No Paravertebral BlockActive Control1 Intervention
Subject will receive no paravertebral block.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,452 Total Patients Enrolled
John Stauffer, M.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot tolerate pain medications like opiates, NSAIDs, acetaminophen, or local anesthetics.I need daily painkillers for chronic pain.I am an adult not pregnant and can have a surgery on my pancreas with a specific pain block.
Research Study Groups:
This trial has the following groups:- Group 1: Paravertebral Block Pre Procedure
- Group 2: No Paravertebral Block
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any potential risks associated with employing a Paravertebral Block Pre Procedure?
"Paravertebral Block Pre Procedure has been greenlit for use, so it achieved a score of 3."
Answered by AI
Are there still opportunities to participate in this experiment for willing subjects?
"According to clinicaltrials.gov, this trial has finished recruiting and is not currently seeking candidates. Posted on April 13th 2023 and last updated on April 6th 2023, 11 other studies are actively enrolling patients at the moment."
Answered by AI
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