Back Pain Lower Back Chronic, Postoperative Pain
Conditions
Keywords
Lumbar surgery, Magnesium sulfate, Pain, Visual analogue score
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.
Interventions
DRUGMagnesium sulfate
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.
DRUGnormal saline
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.
Sponsors
Sisli Hamidiye Etfal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Richmond Agitation-Sedation Scale. | 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. |
| heart rate | 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. |
| sistolic blood pressure | 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. |
| diastolic 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 will recorded in the peri-operative period as mmhg. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRsibel oba
şişli etfal eğitim araştırma hastanesi
Outcome results
None listed