Intrathecal Magnesium and Postoperative Analgesia

Total Hip Replacement Clinical Trial

Official title:

Effects of a Single Dose of Intrathecal Magnesium Sulfate on Postoperative Morphine Consumption After Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560092
• Other study ID #: CHU63-006
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2006
• Last updated: April 2, 2013
• Start date: January 2004
• Est. completion date: October 2008

Study information

• Verified date: April 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years to 93 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Drug:
• intrathecal magnesium sulfate
intrathecal magnesium sulfate

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (2)

Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. — View Citation

Mayer ML, Westbrook GL. Permeation and block of N-methyl-D-aspartic acid receptor channels by divalent cations in mouse cultured central neurones. J Physiol. 1987 Dec;394:501-27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of morphine consumption in the postoperative period.		in the postoperative period	Yes
Secondary	Duration of sensory and motor blockade induced by the intrathecal anesthesia ; side effects; postoperative pain (visual analogue scale).		postoperative pain	Yes