NCT02449486

Brief Summary

Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4 postoperative-pain

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

January 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3.9 years

First QC Date

May 18, 2015

Last Update Submit

April 23, 2018

Conditions

Postoperative Pain

Keywords

Requirement of postoperative pain medication

Outcome Measures

Primary Outcomes (1)

  • Postoperative oxycodone consumption

    postoperative PCA administered oxycodone

    48 postoperative hours

Secondary Outcomes (1)

  • Pain measured with Visual Analog Scale

    48 postoperative hours

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours

Drug: Ropivacaine

Placebo

PLACEBO COMPARATOR

Saline infusion 4 ml/h for 48 hours

Drug: Ropivacaine

Interventions

RopivacaineDRUG
PlaceboRopivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective CABG or heart valve surgery patients

You may not qualify if:

  • Psychic disorders
  • Sleep apnea syndrome
  • Diabetes mellitus (insulin dependent)
  • Obesity, body mass index (BMI) ≥ 35
  • Cardiac insufficiency, ejection fraction (EF) ≤ 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University hospital

Kuopio, FI70029, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pasi K Lahtinen, MD, PhD

    Kuopio University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 20, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Data will be published in a peer reviewed medical publication

Locations

FI(1)