Ketamine Associated With Morphine PCA After Total Hip Arthroplasty

Arthroplasty, Replacement, Hip Clinical Trial

— KETAMINE  

Official title:

Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797264
• Other study ID #: P060402
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: April 10, 2013
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: April 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect.

We will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion.

Description:

Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• total hip arthroplasty

Exclusion Criteria:

• pre operative opioid administration

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Drug:
• Ketamine-Morphine
Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
• Morphine
Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
• Postoperative PCA of Ketamine and morphine
Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)

Locations

Country	Name	City	State
France	Service d'anesthesie-reanimation - Hôpital Bicêtre	Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption in PACU and in hospitalisation room		at 24 and 48 hours	No
Secondary	Postoperative Visual Analogic Score of pain		in Recovery Room, at 24 and 48 hours, in the ward	No
Secondary	Postoperative Measure of mechanical hyperalgesia by Von Frey filament device		24 and 48 hours in the ward	No
Secondary	Postoperative measure Ketamine and Nor-Ketamine blood levels		at 24 and 48 hours in the ward	No