NCT02363777

Brief Summary

Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA. Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery. Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased pain compared to patients treated with thoracic epidural for post-operative pain. Secondary Objectives:

  1. 1.To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
  2. 2.To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

February 3, 2015

Last Update Submit

August 30, 2017

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • total Maximal Pain scored via NRS 0-10 scale

    maximal pain scored via NRS 0-10 scale assessed by independent assessor

    on postoperative day 1 through postoperative day 5

Secondary Outcomes (7)

  • Maximal Pain scored via NRS 0-10 scale

    on postoperative day 1

  • Maximal Pain scored via NRS 0-10 scale

    on postoperative day 2

  • Maximal Pain scored via NRS 0-10 scale

    on postoperative day 3

  • Maximal Pain scored via NRS 0-10 scale

    on postoperative day 4

  • Maximal Pain scored via NRS 0-10 scale

    on postoperative day 5

  • +2 more secondary outcomes

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Epidural placed for postoperative pain control

Procedure: Epidural

Experimental Intervention

EXPERIMENTAL

Bilateral paravertebral catheters placed for postoperative pain control

Procedure: Paravertebral catheters

Interventions

EpiduralPROCEDURE

A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively

Standard of Care
Paravertebral cathetersPROCEDURE

Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively

Experimental Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing open pancreatic surgery.

You may not qualify if:

  • Previous difficult airway or multiple previous intubations
  • History of myasthenic syndrome
  • Systemic infection
  • Pre-existing sensory deficit
  • PT \>14 or PTT \>40 sec
  • Platelet count less than 50,000
  • Creatinine \> 1.5
  • Allergy to local anesthetics
  • Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively
  • Use of a spinal or epidural anesthetic for surgery
  • Daily use of opioid for more than a week or chronic pain syndrome
  • Lack of patient cooperation
  • Contraindication to regional anesthesia
  • Infection at injection site
  • Inability to guarantee sterile equipment or sterile conditions for the block
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 16, 2015

Study Start

August 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

US(1)