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Completed

NCT Number: NCT07418580

Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery

Effective postoperative analgesia after lumbar spine surgery (e.g., laminectomy, vertebroplasty, lumbar stabilization) is associated with faster recovery and shorter hospital stay. Multimodal analgesia aims to reduce opioid consumption and related adverse effects by combining agents with complementary mechanisms of action at peripheral and central levels.

Magnesium is one of the agents used in this approach. Its analgesic effects are attributed to inhibition of neuropathic pain, potentiation of opioid analgesia, and attenuation of opioid tolerance. Mechanistically, magnesium acts as a non-competitive NMDA receptor antagonist and modulates intracellular calcium influx, thereby reducing central glutamate release and limiting hyperalgesia.

However, the clinical efficacy of perioperative magnesium remains controversial. Outcomes may vary depending on timing (intraoperative vs. postoperative), dosing strategies (bolus vs. infusion), and total administered dose. The optimal dosage, administration method, safety profile, and dose-response relationship of magnesium for analgesic purposes are not yet clearly established.

This study aims to evaluate the effectiveness of perioperative low-dose magnesium sulfate (MgSO₄) in this context.

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Key information

Conditions

Postoperative Pain Back Pain Lower Back Chronic Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18 years and older,
  • ASA (American Society of Anesthesiologists) physical status I-II,
  • awaiting to undergo lumbar spinal surgery under general anesthesia.

Exclusion criteria

  • the presence of cardiac conduction disorders and/or cardiac comorbidities
  • use of Ca channel blockers,
  • hepatic/renal failure and allergy to Mg.

Treatment and study plan

Magnesium sulfate

Drug

Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of MgSO4 (10 mg/kg/h) in 100 mL of normal saline (NS) was initiated in groups C, respectively.

normal saline

Drug

Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of 100 mL of NS (10 mg/kg/h) was initiated in groups m, respectively.

Primary outcomes

  1. visual analog scale

    Time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.

    The Visual Analog Scale (VAS) is a unidimensional tool used to measure pain intensity. It typically consists of a 10-cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10), on which patients mark the point that best represents their perceived pain level.

Secondary outcomes

  1. Richmond Agitation-Sedation Scale.

    Time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.

    The Richmond Agitation-Sedation Scale (RASS) is a validated clinical tool used to assess the level of agitation and sedation in hospitalized patients, particularly in intensive care settings. It ranges from +4 (combative) to -5 (unarousable), allowing clinicians to monitor and titrate sedative and analgesic therapy effectively.

  2. heart rate

    Time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period

    heart rate will recorded in the peri-operative period.

  3. sistolic blood pressure

    Time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period

    sistolic blood pressure will recorded in the peri-operative period as mmhg.

  4. diastolic blood pressure

    Time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period

    diastolic blood pressure will recorded in the peri-operative period as mmhg.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

The Effects of Perioperative Low-dose Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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