Postoperative PainNCT07418580
Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery
A study testing Magnesium sulfate and normal saline in people with Postoperative Pain and Back Pain Lower Back Chronic, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Effective postoperative analgesia after lumbar spine surgery (e.g., laminectomy, vertebroplasty, lumbar stabilization) is associated with faster recovery and shorter hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Back Pain Lower Back Chronic
- What is being tested?
- Magnesium sulfate and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years and older,
- ASA (American Society of Anesthesiologists) physical status I-II,
- awaiting to undergo lumbar spinal surgery under general anesthesia.
Who cannot join
- the presence of cardiac conduction disorders and/or cardiac comorbidities
- use of Ca channel blockers,
- hepatic/renal failure and allergy to Mg.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli etfal research and training hospital
Istanbul, 34371
About this study
Official title: The Effects of Perioperative Low-dose 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.
Read more
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
- Being tested
- Magnesium sulfate, normal saline
- Keywords
- Lumbar surgery, Magnesium sulfate, Pain, Visual analogue score
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
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 salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
Secondary outcomes (4)
Richmond Agitation-Sedation Scale.
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.
Measured: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
heart rate
heart rate will recorded in the peri-operative period.
Measured: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
sistolic blood pressure
sistolic blood pressure will recorded in the peri-operative period as mmhg.
Measured: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
diastolic blood pressure
diastolic blood pressure will recorded in the peri-operative period as mmhg.
Measured: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2021
- Primary completion1 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysel Salkaya, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- sibel oba, Study chair, şişli etfal eğitim araştırma hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418580
- Sponsor's protocol ID
- salkaya-2
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Perioperative Low-dose Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery
- ClinicalTrials.gov ID
- NCT07418580
- Acronym / sponsor ID
- salkaya-2
- Conditions
- Postoperative Pain, Back Pain Lower Back Chronic
- Keywords
- Lumbar surgery, Magnesium sulfate, Pain, Visual analogue score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the magnesium treatment group (Group M) | Experimental | Drug: Magnesium sulfateInitial 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. |
| the control group (Group C) | Active comparator | Drug: normal salineInitial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years and older,
- ASA (American Society of Anesthesiologists) physical status I-II,
- awaiting to undergo lumbar spinal surgery under general anesthesia.
Key exclusion criteria (3 listed)
- the presence of cardiac conduction disorders and/or cardiac comorbidities
- use of Ca channel blockers,
- hepatic/renal failure and allergy to Mg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateInitial 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. | Drug | the magnesium treatment group (Group M) |
| normal salineInitial 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. | Drug | the control group (Group C) |
Primary outcome
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.
4 secondary outcomes
Richmond Agitation-Sedation Scale.
Time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
heart rate
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
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
Time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sibel oba study chair
şişli etfal eğitim araştırma hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate and normal saline in people with Postoperative Pain and Back Pain Lower Back Chronic, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (time frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.