Intrathecal Magnesium and Postoperative Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00560092
First received: June 22, 2006
Last updated: April 2, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   56 Years to 93 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 22, 2006
Last Updated: April 2, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 30, 2014