Paravertebral Block vs no Block in Open Pancreaticoduodenectomy

NCT05820997 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 22-012297
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  First 48 hours after surgery

Secondary Outcomes (2)

• Hospital Length of Stay

  Approximately 4-6 days post surgery

• Number of Subjects With a Bowel Obstruction

  Approximately 2-4 days

Study Arms (2)

Paravertebral Block Pre Procedure

ACTIVE COMPARATOR

Subject will receive a preoperative paravertebral block only

Drug: Ropivacaine

No Paravertebral Block

NO INTERVENTION

Subject will receive no paravertebral block.

Interventions

Ropivacaine DRUG

Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level

Paravertebral Block Pre Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing and have signed consent.
• Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The study was terminated due to low accrual.

Results Point of Contact

• Title: Dr. John Stauffer
• Organization: Mayo Clinic

stauffer.john@mayo.edu

904-953-2000

Study Officials

• John Stauffer, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 20, 2023
• Study Start: April 24, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)