A Phase 4 interventional study of Ropivacaine in Pancreaticoduodenectomy, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Supportive care
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject will receive a preoperative paravertebral block only
Drug: Ropivacaine
Subject will receive no paravertebral block.
Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level
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.
Time frame: First 48 hours after surgery
Hospital Length of Stay
Total number of days subjects were admitted to the hospital following surgery
Time frame: Approximately 4-6 days post surgery
Number of Subjects With a Bowel Obstruction
Number of subjects to experience a bowl obstruction following surgery
Time frame: Approximately 2-4 days
| Milestone | Paravertebral Block Pre Procedure | No Paravertebral Block |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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.
| score on a scale | Paravertebral Block Pre Procedure | No Paravertebral Block |
|---|---|---|
| Mean Post-operative Pain Score | 5 (2 to 8) | 4 (0 to 8) |
Total number of days subjects were admitted to the hospital following surgery
| days | Paravertebral Block Pre Procedure | No Paravertebral Block |
|---|---|---|
| Hospital Length of Stay | 5 | 6 |
Number of subjects to experience a bowl obstruction following surgery
| Participants | Paravertebral Block Pre Procedure | No Paravertebral Block |
|---|---|---|
| Number of Subjects With a Bowel Obstruction | 0 | 0 |
Collected over Adverse events were collected from the time of surgery until time of discharge, approximately 6 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paravertebral Block Pre Procedure | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| No Paravertebral Block | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Paravertebral Block Pre Procedure | No Paravertebral Block |
|---|---|---|
| lleusGastrointestinal disorders | 0/1 | 1/1 |
| Age, Categorical(Participants) | Paravertebral Block Pre Procedure | No Paravertebral Block | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Paravertebral Block Pre Procedure | No Paravertebral Block | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Paravertebral Block Pre Procedure | No Paravertebral Block | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Paravertebral Block Pre Procedure | No Paravertebral Block | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
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