Intrathecal Magnesium and Postoperative Analgesia
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 22, 2006 | ||||
| Last Updated Date | April 2, 2013 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction of morphine consumption in the postoperative period. [ Time Frame: in the postoperative period ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Reduction of morphine consumption in the postoperative period. | ||||
| Change History | Complete list of historical versions of study NCT00560092 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
Duration of sensory and motor blockade induced by the intrathecal anesthesia ; side effects; postoperative pain (visual analogue scale). | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intrathecal Magnesium and Postoperative Analgesia | ||||
| Official Title ICMJE | Effects of a Single Dose of Intrathecal Magnesium Sulfate on Postoperative Morphine Consumption After Total Hip Replacement | ||||
| Brief Summary | 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. |
||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE | Total Hip Replacement | ||||
| Intervention ICMJE | Drug: intrathecal magnesium sulfate
intrathecal magnesium sulfate |
||||
| Study Arm (s) | Experimental: intrathecal magnesium sulfate
Intervention: Drug: intrathecal magnesium sulfate |
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 56 Years to 93 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00560092 | ||||
| Other Study ID Numbers ICMJE | CHU63-006 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University Hospital, Clermont-Ferrand | ||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University Hospital, Clermont-Ferrand | ||||
| Verification Date | April 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||