Intrathecal Magnesium and Postoperative Analgesia

Phase 3

Completed

• Conditions: Total Hip Replacement
• Interventions: Drug: intrathecal magnesium sulfate

• Registration Number: NCT00560092
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intrathecal magnesium sulfate	intrathecal magnesium sulfate	-

Primary Outcome Measures

Name	Time	Method
Reduction of morphine consumption in the postoperative period.	in the postoperative period

Secondary Outcome Measures

Name	Time	Method
Duration of sensory and motor blockade induced by the intrathecal anesthesia ; side effects; postoperative pain (visual analogue scale).	postoperative pain

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Auvergne, France