Ketamine Associated With Morphine PCA After Total Hip Arthroplasty

NCT00797264 | Completed

• 1 other identifier: P060402
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Ketamine; Morphine; PCA; Hyperalgesia; Nor-ketamine

Outcome Measures

Primary Outcomes (1)

• Morphine consumption in PACU and in hospitalisation room

  at 24 and 48 hours

Secondary Outcomes (3)

• Postoperative Visual Analogic Score of pain

  in Recovery Room, at 24 and 48 hours, in the ward

• Postoperative Measure of mechanical hyperalgesia by Von Frey filament device

  24 and 48 hours in the ward

• Postoperative measure Ketamine and Nor-Ketamine blood levels

  at 24 and 48 hours in the ward

Study Arms (3)

A

EXPERIMENTAL

Ketamine pre and per operative, and morphine postoperative

Drug: Ketamine-Morphine

B

ACTIVE COMPARATOR

NaCl pre and per operative, and morphine postoperative

Drug: Morphine

C

EXPERIMENTAL

Ketamine and morphine postoperative

Drug: Postoperative PCA of Ketamine and morphine

Interventions

Ketamine-Morphine DRUG

Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)

Also known as: Ketamine pre and per operative, and morphine postoperative

A

Morphine DRUG

Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)

B

Postoperative PCA of Ketamine and morphine DRUG

Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)

Also known as: Ketamine Morphine

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• total hip arthroplasty

You may not qualify if:

• pre operative opioid administration

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'anesthesie-reanimation - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Hyperalgesia

Interventions

Morphine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Philippe SITBON, MD

  Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

FR (1)