NCT00822133

Brief Summary

Since VAT bears with it severe postopearive pain, and since ketamine has been shown to be an optimal analgesics adjuvant for postoperative pain, we wish to assess to effects of ketamie vs. lidocaine if put on the skin in the sites where scopes are interset into the chest for thoracoscopy.

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 postoperative-pain

Timeline
Completed

Started Feb 2009

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

Postoperative Pain

Keywords

ketaminepreemptionpostoperativepainsafety

Outcome Measures

Primary Outcomes (1)

  • reduce postoeprative pain

    up to 3 months

Secondary Outcomes (1)

  • overall patient satisfaction

    up to 3 months

Study Arms (3)

lodocaine

ACTIVE COMPARATOR

lidocaine 5% cream will be put on the skin

Drug: lidocaine

ketamine

EXPERIMENTAL

ketamine 5% will be put on the skin

Drug: ketamine

placebo

PLACEBO COMPARATOR

non-active cream will be put on the skin

Drug: non-active drug cream

Interventions

lidocaineDRUG

lidocaine 5%

lodocaine
ketamineDRUG

ketamine cream

ketamine
non-active 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 VAT

You may not qualify if:

  • emergency patients, open thoracotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

LidocaineKetamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

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)