Ropivacaine After Sternotomy

NCT ID: NCT02449486

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ropivacaine

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Placebo

Saline infusion 4 ml/h for 48 hours

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective CABG or heart valve surgery patients

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pasi K Lahtinen, MD, PhD

Role: STUDY_DIRECTOR

Kuopio University Hospital

Locations

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Kuopio University hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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5070221

Identifier Type: -

Identifier Source: org_study_id

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