PancreaticoduodenectomyPhase 4NCT05820997
Paravertebral Block vs no Block in Open Pancreaticoduodenectomy
A Phase 4 study testing Ropivacaine in people with Pancreaticoduodenectomy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 4 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing and have signed consent.
- Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paravertebral Block vs no Block in Open Pancreaticoduodenectomy: Prospective Randomized Controlled Trial
The purpose 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 the investigator plans 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.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block Pre Procedure | Active comparator | Subject will receive a preoperative paravertebral block only Receives: Drug: Ropivacaine |
| No Paravertebral Block | No intervention | Subject will receive no paravertebral block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Post-operative Pain Score
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. The average score across the 11 questions was calculated for each subject using the minimum and maximum values reported for each subject across the 11 questions.
Measured: First 48 hours after surgery
Secondary outcomes (2)
Hospital Length of Stay
Total number of days subjects were admitted to the hospital following surgery
Measured: Approximately 4-6 days post surgery
Number of Subjects With a Bowel Obstruction
Number of subjects to experience a bowl obstruction following surgery
Measured: Approximately 2-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start24 Apr 2023
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John A. Stauffer, Mayo Clinic
- Investigators
- John Stauffer, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820997
- Sponsor's protocol ID
- 22-012297
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2023
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block vs no Block in Open Pancreaticoduodenectomy: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05820997
- Acronym / sponsor ID
- 22-012297
- Conditions
- Pancreaticoduodenectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose 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 the investigator plans 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block Pre Procedure | Active comparator | Drug: RopivacaineSubject will receive a preoperative paravertebral block only |
| No Paravertebral Block | No intervention | –Subject will receive no paravertebral block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients willing and have signed consent.
- Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineParavertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level | Drug | Paravertebral Block Pre Procedure |
Primary outcome
Mean Post-operative Pain Score
Time frame: First 48 hours after surgery
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. The average score across the 11 questions was calculated for each subject using the minimum and maximum values reported for each subject across the 11 questions.
2 secondary outcomes
Hospital Length of Stay
Time frame: Approximately 4-6 days post surgery
Number of Subjects With a Bowel Obstruction
Time frame: Approximately 2-4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Patients Who Undergo Pancreaticoduodenectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Stauffer, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Pancreaticoduodenectomy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Post-operative Pain Score (time frame: First 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.