Effects of Intraoperative Magnesium Sulfate on Perioperative Pain Relief After Spine Surgery

NCT04161729 | Completed Phase 4

• 1 other identifier: SpiMag
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of postoperative pain is increasingly based on a multimodal approach and although opioids remain the drug of choice, they are often used in combination with other analgesics (paracetamol, cyclooxygenase inhibitors or non-steroidal anti-inflammatory drugs) and co-analgesic agents (clonidine and anti- NMDA such as ketamine or MgSO4). The rationale for combined analgesia is to achieve additive or synergistic analgesic properties while decreasing the incidence of side effects by reducing the dose of each agent. Nociceptive stimuli are known to activate the release of the excitatory amino acid glutamate in the dorsal horn of the spinal cord. The resultant activation of NMDA receptors causes calcium entry into the cell and triggers central sensitisation. This mechanism is involved in the perception of pain and mainly accounts for its persistence during the postoperative period. Although magnesium is not a primary analgesic in itself, it enhances the analgesic actions of more established analgesics as an adjuvant agent. Magnesium produces a voltage-dependent block of NMDA receptors and has been reported to have analgesic properties that might be related to this inhibiting property. Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic and endocrine reflexes provoked by noxious stimuli. When magnesium was used intraoperatively, many researchers reported that it reduced the requirement for anesthetics and/or muscle relaxants. Intraoperative use of magnesium sulfate can also be associated with decreased incidences of nausea and vomiting after surgery, which could have been due to the lower consumption of anesthetics (i.e. volatile agents), rather than any antiemetic effect of magnesium sulfate. In addition, perioperative i.v. administration of magnesium sulfate has another advantageous effect, as it decreases the incidence of shivering by up to 70-90%. Previous studies investigating the analgesic efficacy of MgSO4 in general, gynaecological, ophthalmic and orthopaedic surgery have shown conflicting results, while reports regarding spine surgery are extremely limited. Our study was designed to investigate the effects of MgSO4 on perioperative pain relief and postoperative quality of recovery after lumbar laminectomy surgery.

Conditions

Analgesia; Pain, Postoperative; Spine Disease

Keywords

magnesium; analgesia; pain score; opioid consumption; spine surgery

Outcome Measures

Primary Outcomes (1)

• Analgesics consumption postoperatively in morphine equivalents

  The difference in analgesic consumption (assessed as mg of morphine equivalents) postoperatively after intravenous infusion of magnesium sulfate or isotonic saline 0.9%

  24 hours after the emergence from anesthesia

Secondary Outcomes (3)

• Analgesics consumption intraoperatively

  180 minutes intraoperatively

• Pain intensity

  10 minutes after emergence from anesthesia, 2, 4 and 6 hours after the emergence from anesthesia

• Time to first analgesic request in minutes

  24 hours after the emergence from anesthesia

Other Outcomes (4)

• Heart rate changes intraoperatively

  180 minutes intraoperatively

• Systemic blood pressure changes intraoperatively

  180 minutes intraoperatively

• Postoperative adverse effects

  24 hours after the emergence from anesthesia

Study Arms (2)

Magnesium sulfate

ACTIVE COMPARATOR

Magnesium sulfate 20 mg/kg intravenous over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.

Drug: Magnesium Sulfate; Drug: Isotonic saline 0.9%

Isotonic solution 0.9%

PLACEBO COMPARATOR

Isotonic solution 0.9% in the same volume as the study drug using identical pattern of administration.

Drug: Magnesium Sulfate; Drug: Isotonic saline 0.9%

Interventions

Magnesium Sulfate DRUG

Intravenous magnesium sulfate 20 mg/kg in 100ml isotonic saline 0.9% over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.

Isotonic solution 0.9%; Magnesium sulfate

Isotonic saline 0.9% DRUG

Isotonic saline 0.9% 100ml over a 15-min period before induction of anesthesia and thereafter continuous i.v. infusion until surgery completion in dosage identical to magnesium sulfate group.

Isotonic solution 0.9%; Magnesium sulfate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged between 18 and 80 years
• ASA Physical status 1 to 3
• Elective or semi-elective lumbar laminectomy surgery
• Signed informed consent

You may not qualify if:

• Under medication with calcium channel blockers or magnesium
• Drugs or alcohol abuse
• Neurological disorders
• Myopathy
• Intracardiac block
• Hepatic failure
• Renal failure
• Pregnancy

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Spinal Diseases

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Georgia Tsaousi

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 13, 2019
• Study Start: January 28, 2020
• Primary Completion: May 3, 2020
• Study Completion: May 5, 2020
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)