Intrathecal Magnesium and Postoperative Analgesia - Full Text View

Sponsor:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00560092

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 III

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:

MedlinePlus related topics: Hip Replacement

Drug Information available for: Magnesium sulfate Magnesium

U.S. FDA Resources

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2004
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560092

Contacts

Contact: Christian Duale, Doctor

(33) 04 73 751 590

cduale@chu-clermontferrand.fr

Locations

France
Clermont-Ferrand University Hospital	Recruiting
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:

Mayer ML, Westbrook GL. Permeation and block of N-methyl-D-aspartic acid receptor channels by divalent cations in mouse cultured central neurones. J Physiol. 1987 Dec;394:501-27.

Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents.

Responsible Party:	Dr Christian DUALE, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00560092 History of Changes
Other Study ID Numbers:	CHU63-006
Study First Received:	June 22, 2006
Last Updated:	January 18, 2011
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 February 12, 2012