NCT00586976

Brief Summary

Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.

Trial Health

57
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Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

December 21, 2007

Last Update Submit

April 6, 2015

Conditions

Cardiac Surgery

Keywords

pain, ropivacaine, infusion, sternotomy

Outcome Measures

Primary Outcomes (1)

  • Visual analog pain

    64 hours

Secondary Outcomes (3)

  • drug toxicity

    64 hours

  • infection

    64 hours

  • narcotic usage

    64 hours

Study Arms (2)

1

EXPERIMENTAL

Ropivicaine infusion into the sternal wound

Drug: Ropivacaine

2

PLACEBO COMPARATOR

Normal saline infusion into the sternal wound

Drug: Normal saline

Interventions

RopivacaineDRUG

0.3% ropivacaine infusion at 4 ml/hr for 64 hours.

1
Normal salineDRUG

Normal saline infusion at 4 ml/hour for 64 hours.

2

Eligibility Criteria

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

You may qualify if:

  • Be greater than 18 years of age
  • Be undergoing a cardiac surgical procedure via median sternotomy (i.e., exclude the occasional thoracotomy, since much greater pain with that surgical approach post-operatively)

You may not qualify if:

  • Are unable to grant informed consent or comply with study procedure
  • Are undergoing emergency open heart-surgery
  • Allergic to any of the excipients in ropivacaine, propofol, and fentanyl
  • Age \< 18 years of age (children have dosing and toxicity concerns)
  • Are pregnant (pregnancy changes pain thresholds)
  • Taking preoperative opioids. (Opioid tolerant patients will require significantly more post-operative opioid use.)
  • Cirrhosis or hepatic failure (may have accumulation of local anesthetic in plasma due to decreased metabolism)
  • Patient receiving lidocaine infusion prior to surgery. (An extremely rare event)
  • Patients having a planned circulatory arrest for their surgical procedure (increased duration of intubation possible)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Agarwal S, Nuttall GA, Johnson ME, Hanson AC, Oliver WC Jr. A prospective, randomized, blinded study of continuous ropivacaine infusion in the median sternotomy incision following cardiac surgery. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):145-50. doi: 10.1097/AAP.0b013e318281a348.

    PMID: 23386053DERIVED

MeSH Terms

Conditions

Pain

Interventions

RopivacaineSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Gregory A. Nuttall, M.D.

    Mayo Clinic College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

July 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)