NCT04161729

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

Completed Phase 4 Last updated 14 May 2020

What this trial tests

Phase 4 trial testing Magnesium Sulfate in Analgesia in 74 participants. Completed in 5 May 2020.

Timeline

28 January 2020

Primary endpoint
3 May 2020

5 May 2020

Quick facts

Lead sponsor	Aristotle University Of Thessaloniki
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	74
Start date	28 January 2020
Primary completion	3 May 2020
Estimated completion	5 May 2020
Sites	1 location across Greece

Drugs / interventions tested

• Magnesium Sulfate — full drug profile →
• Isotonic saline 0.9%

Conditions studied

• Analgesia — all drugs for Analgesia →
• Pain, Postoperative — all drugs for Pain, Postoperative →
• Spine Disease — all drugs for Spine Disease →

Sponsor

Aristotle University Of Thessaloniki

Who can join

Adults 18 to 80, any sex, with Analgesia or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacological Efficacy of Intravenous Magnesium in Attenuating Remifentanil-Induced Postoperative Hyperalgesia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
   Wu EB, Wu KL, Hsu WT, Yuan WC, et al · · 2025 · cited 3× · PMID 40283953 · DOI 10.3390/ph18040518