Intrathecal Magnesium and Postoperative Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Total Hip Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intrathecal magnesium sulfate

Group Type EXPERIMENTAL

intrathecal magnesium sulfate

Intervention Type DRUG

intrathecal magnesium sulfate

Interventions

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intrathecal magnesium sulfate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

56 Years

Maximum Eligible Age

93 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No