| June 22, 2006 |
| October 7, 2008 |
| 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). |
| |
| 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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
| Total Hip Replacement |
| Drug: intrathecal magnesium sulfate |
| |
|
|
| |
| Recruiting |
| 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 |
|
|
| France |
| |
| NCT00560092 |
| Dr Christian DUALE, CHU Clermont-Ferrand |
| CHU63-006 |
| University Hospital, Clermont-Ferrand |
| University Hospital |
| Principal Investigator: |
Christian Duale, Dr |
University Hospital, Clermont-Ferrand |
|
|
| University Hospital, Clermont-Ferrand |
| October 2008 |
