Intrathecal Magnesium and Postoperative Analgesia

NCT00560092 | Completed Phase 3

• 1 other identifier: CHU63-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement

Keywords

Magnesium; Pain; Morphine; Intrathecal; NMDA; Elective total hip replacement under intrathecal anesthesia

Outcome Measures

Primary Outcomes (1)

• Reduction of morphine consumption in the postoperative period.

  in the postoperative period

Secondary Outcomes (1)

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

  postoperative pain

Study Arms (1)

intrathecal magnesium sulfate

EXPERIMENTAL

Drug: intrathecal magnesium sulfate

Interventions

intrathecal magnesium sulfate DRUG

intrathecal magnesium sulfate

intrathecal magnesium sulfate

Eligibility Criteria

• Age: 56 Years - 93 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total hip replacement under intrathecal anesthesia.

You may not qualify if:

• General anesthesia (alone or not)
• Intolerance to morphine
• Misunderstanding of the use of the device for intravenous patient-controlled administration of morphine.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63000, France

Location

Related Publications (2)

• 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. doi: 10.1113/jphysiol.1987.sp016883.

  PMID: 2451020 BACKGROUND

• 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. doi: 10.1097/00000539-200209000-00031.

  PMID: 12198056 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Duale, Dr

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: November 19, 2007
• Study Start: January 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

FR (1)