Clinical trial

Paravertebral Block vs no Block in Open Pancreaticoduodenectomy: Prospective Randomized Controlled Trial

NCT05820997

Name

22-012297

Description

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.

Trial arms

Trial start

2023-04-24

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Ropivacaine

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

Arms:

Paravertebral Block Pre Procedure

Size

Primary endpoint

Mean post-operative pain score

First 48 hours after surgery

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-04-26

1 organization

1 product

1 indication

Organization

Mayo Clinic

Product

Ropivacaine

Indication

Pancreaticoduodenectomy