Paravertebral Block Vs No Block in Open Pancreaticoduodenectomy

Phase 4

Terminated

• Conditions: Pancreaticoduodenectomy
• Interventions: Drug: Ropivacaine

• Registration Number: NCT05820997
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-20
• Study Start: 2023-04-24
• Primary Completion: 2024-12-04
• Study Completion: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral Block Pre Procedure	Ropivacaine	Subject will receive a preoperative paravertebral block only

Primary Outcome Measures

Name	Time	Method
Mean post-operative pain score	First 48 hours after surgery	Measured using pain visual analog scale, with pain scale ranging from 0 to 10 (0=no pain; 10=worst possible pain)

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	Approximately 2-4 days	Total number of days subjects were admitted to the hospital following surgery
Number of subjects with a bowel obstruction	Approximately 2-4 days	Number of subjects to experience a bowl obstruction following surgery

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States