NCT00822419

Brief Summary

Since midsternotomy is painful postoepratively, and since ketamine has been shown to be optimal postoeprative analgessic adjuvant, the investigators wish to assess its percutaneous preemptive effect, comparing it to lidocaine effect.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Sternotomy

Keywords

sternotomy pain

Outcome Measures

Primary Outcomes (1)

  • Reduced postoperative pain

    3 months

Secondary Outcomes (1)

  • Overall satisfaction

    3 months

Study Arms (3)

lidocaine

ACTIVE COMPARATOR

Lidocaine 5% cream 5 gr will be double blindly put on the skin preoperatively

Drug: lidocaine

ketamine

EXPERIMENTAL

ketamine cream 5% 5gr will be put on the skin preoperatively

Drug: ketamine

placebo

SHAM COMPARATOR

non-drug similar cream will be put on the skin preoperatively

Drug: non-drug cream

Interventions

lidocaineDRUG

lidocaine cream 5%

lidocaine
ketamineDRUG

ketamine 5%

ketamine
non-drug creamDRUG

will be put on the skin

placebo

Eligibility Criteria

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

You may qualify if:

  • all patients undergoing sternoromy for cardiac or chest sturgery

You may not qualify if:

  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Interventions

LidocaineKetamine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Avi A Weinbroum, MD

CONTACT

972-3-697-3237draviw@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

IL(1)