Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery

NCT07418580 | Completed

• 1 other identifier: salkaya-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Back Pain Lower Back Chronic

Keywords

Lumbar surgery; Magnesium sulfate; Pain; Visual analogue score

Outcome Measures

Primary Outcomes (1)

• visual analog scale

  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.

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

Secondary Outcomes (4)

• Richmond Agitation-Sedation Scale.

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

• heart rate

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

• sistolic blood pressure

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

• diastolic blood pressure

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

Study Arms (2)

the magnesium treatment group (Group M)

EXPERIMENTAL

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 M, respectively.

Drug: Magnesium sulfate

the control group (Group C)

ACTIVE COMPARATOR

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

Drug: normal saline

Interventions

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.

the magnesium treatment group (Group M)

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.

the control group (Group C)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• sibel oba

  şişli etfal eğitim araştırma hastanesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 30, 2021
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

TU (1)