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Intrathecal Magnesium and Postoperative Analgesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560092
First Posted: November 19, 2007
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose
Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system [1]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.

Condition Intervention Phase
Total Hip Replacement Drug: intrathecal magnesium sulfate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Single Dose of Intrathecal Magnesium Sulfate on Postoperative Morphine Consumption After Total Hip Replacement

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Reduction of morphine consumption in the postoperative period. [ Time Frame: in the postoperative period ]

Secondary Outcome Measures:
  • Duration of sensory and motor blockade induced by the intrathecal anesthesia ; side effects; postoperative pain (visual analogue scale). [ Time Frame: postoperative pain ]

Enrollment: 40
Study Start Date: January 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intrathecal magnesium sulfate Drug: intrathecal magnesium sulfate
intrathecal magnesium sulfate

Detailed Description:
Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system [1]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years to 93 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total hip replacement under intrathecal anesthesia.

Exclusion Criteria:

  • General anesthesia (alone or not)
  • Intolerance to morphine
  • Misunderstanding of the use of the device for intravenous patient-controlled administration of morphine.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560092


Locations
France
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Christian Duale, Dr University Hospital, Clermont-Ferrand
  More Information

Publications:
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00560092     History of Changes
Other Study ID Numbers: CHU63-006
First Submitted: June 22, 2006
First Posted: November 19, 2007
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by University Hospital, Clermont-Ferrand:
Magnesium
Pain
Morphine
Intrathecal
NMDA
Elective total hip replacement under intrathecal anesthesia

Additional relevant MeSH terms:
Morphine
Magnesium Sulfate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents