Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.

NCT ID: NCT00726258

Last Updated: 2014-08-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Drip of physiological serum

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

physiological serum

2

Drip of ketamine

Group Type ACTIVE_COMPARATOR

ketamine

Intervention Type DRUG

ketamine with various concentrations

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ketamine

ketamine with various concentrations

Intervention Type DRUG

placebo

physiological serum

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject between 18 and 85 years
* subject of both sexes
* subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject
* subject operated in settled surgery

Exclusion Criteria

* Against indication in the epidural insanity,
* confusionnel, patient psychotic
* treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Françoise GAILLAT, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hôpitaux de Marseille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite

Marseille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Joseph C, Gaillat F, Duponq R, Lieven R, Baumstarck K, Thomas P, Penot-Ragon C, Kerbaul F. Is there any benefit to adding intravenous ketamine to patient-controlled epidural analgesia after thoracic surgery? A randomized double-blind study. Eur J Cardiothorac Surg. 2012 Oct;42(4):e58-65. doi: 10.1093/ejcts/ezs398. Epub 2012 Jul 12.

Reference Type DERIVED
PMID: 22790008 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-04

Identifier Type: -

Identifier Source: secondary_id

2007-00336-20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention of Post Mastectomy With Intraoperative Ketamine
NCT03090776 ACTIVE_NOT_RECRUITING EARLY_PHASE1