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

June 22, 2006
April 2, 2013
January 2004
October 2008   (final data collection date for primary outcome measure)
Reduction of morphine consumption in the postoperative period. [ Time Frame: in the postoperative period ] [ Designated as safety issue: Yes ]
Reduction of morphine consumption in the postoperative period.
Complete list of historical versions of study NCT00560092 on ClinicalTrials.gov Archive Site
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 ]
Duration of sensory and motor blockade induced by the intrathecal anesthesia ; side effects; postoperative pain (visual analogue scale).
Not Provided
Not Provided
 
Intrathecal Magnesium and Postoperative Analgesia
Effects of a Single Dose of Intrathecal Magnesium Sulfate on Postoperative Morphine Consumption After Total Hip Replacement

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Total Hip Replacement
Drug: intrathecal magnesium sulfate
intrathecal magnesium sulfate
Experimental: intrathecal magnesium sulfate
Intervention: Drug: intrathecal magnesium sulfate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
56 Years to 93 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00560092
CHU63-006
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Christian Duale, Dr University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP