AnalgesiaNCT04603638
The Comparison of Analgesia Methods Used for Spinal Surgery
A study testing Magnesium and Isotonic in people with Analgesia and Postoperative Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study ; Two randomized groups will be created. Iv magnesium will be given to one of the blindly designated groups. The other group will be given only isotonic. All patients will be awakened after the analgesic agents (0,1mg / kg morphine, 15mg / kg paracetamol, nsaid) are used in routine practice and will be… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesia, Postoperative Pain
- What is being tested?
- Magnesium and Isotonic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2020to 14 Feb 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 -75 years old
- Patients with posterior instrumentation surgery of 3 or more levels under general anesthesia with a cobb angle of 40 degrees and above
- Patients who will be awakened after the surgery is completed and intensive care follow-up
- Patients with ASA classification 1-3
- Patients with creatine value <1.3 g / dl
Who cannot join
- Having a history of chronic neuropathic pain
- Having a psychiatric illness
- Patients who should not be awakened after surgery but should be followed up intubated and sedated
- Patients who cannot provide adequate cooperation for scoring
- Patients with chronic opioid use and / or substance use
- Patients with ASA classification> 3
- Patients with a creatinine value of 1.3 g / dl and higher
Trial locations and contacts
1 site in 1 country.
About this study
In this study ; Two randomized groups will be created. Iv magnesium will be given to one of the blindly designated groups. The other group will be given only isotonic. All patients will be awakened after the analgesic agents (0,1mg / kg morphine, 15mg / kg paracetamol, nsaid) are used in routine practice and will be followed up for intensive care.
The use of PCA (patient controlled analgesia) device is available in both groups.In post-operative period, magnesium infusion will be continued for 12 h. Only 100cc isotonic will be given without using magnesium to the other group. VAS (visual analog scale) score will be recorded at postoperative 30. minutes and 2,6,12,18,24 hours. In routine administration, the patient should be given 2 mg of morphine if vas>4 and the maximum dose will be increased to 10 mg.
Read the detailed description
After the approval of the ethics committee for the study, in the Istanbul University Faculty of Medicine Orthopedics and Traumatology Department; There will be 3 or more posterior instrumentation operations, cobb angle of 40 degrees and above, 18-75 years old, ASA (American Society of Anesthesiologists) score 1-3, no chronic neuropathic pain and no psychiatric illness, no chronic narcotic analgesics and / or substance abuse a creatine value below 1.3 will be included.
Standard anesthesia monitoring will be performed for patients taken to the operation room. Routine anesthesia induction will be performed. In the prone position, anesthesia maintenance will be provided using the infusion of propofol and remifentanil.
Our clinic; PCA (patient-controlled analgesia) device with intravenous morphine is used routinely for postoperative analgesia.In this study ;two randomized groups will be created. It will give iv magnesium(in the intraoperative period at a dose of 40mg / kg, within 30 minutes after induction) to a blindly designated group. The other group will be given only isotonic. After in post-operative period, magnesium infusion will be continued for 12 hours (40mg / kg). Magnesium sulfate will be given in 100 cc isotonic. In the other group, only 100cc isotonic will be given without using magnesium. All patients will be awakened after the analgesic agents (0,1mg / kg morphine, 15mg / kg paracetamol, nsaid) are used in routine practice and will be followed up for intensive care.
The use of PCA device is available in both groups. vas score will be recorded postoperative 30. minutes and 2,6,12,18,24 hours. In routine administration, the patient should be given 2 mg of morphine if vas>4 and the maximum dose will be increased to 10 mg.
- Conditions
- Analgesia, Postoperative Pain
- Being tested
- Magnesium, Isotonic
- Keywords
- magnesium, morphine, scoliosis
- Medical subject headings
- Agnosia, Pain, Postoperative, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
Also called NMDA (n-metil d aspartat) blocker
40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h)
IsotonicDrug
Also called Saline
100 ml
| Study group | Role | What they receive |
|---|---|---|
| magnesium | Active comparator | participations will be given intravenous magnesium. Receives: Drug: Magnesium |
| control | Placebo comparator | participations will be given intravenous isotonic. Receives: Drug: Isotonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Cumulative morphine consumption during the first 24 postoperative hours measured by patient-controlled analgesia (PCA)
Measured: 24 hours
Secondary outcomes (1)
VAS score
Postoperative pain intensity assessed using the Visual Analog Scale (VAS, 0-10)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start4 Oct 2020
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Hundur, Istanbul University
- Investigators
- Mehmet Ilke Buget, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603638
- Sponsor's protocol ID
- 2019/1458
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jabbour HJ, Naccache NM, Jawish RJ, Abou Zeid HA, Jabbour KB, Rabbaa-Khabbaz LG, Ghanem IB, Yazbeck PH. Ketamine and magnesium association reduces morphine consumption after scoliosis surgery: prospective randomised double-blind study. Acta Anaesthesiol Scand. 2014 May;58(5):572-9. doi: 10.1111/aas.12304. Epub 2014 Mar 17.
PubMed 24635528
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Analgesia Methods Used for Spinal Surgery
- ClinicalTrials.gov ID
- NCT04603638
- Acronym / sponsor ID
- 2019/1458
- Conditions
- Analgesia, Postoperative Pain
- Keywords
- magnesium, morphine, scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 27 Oct 2020 (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.
In this study ; Two randomized groups will be created. Iv magnesium will be given to one of the blindly designated groups. The other group will be given only isotonic. All patients will be awakened after the analgesic agents (0,1mg / kg morphine, 15mg / kg paracetamol, nsaid) are used in routine practice and will be followed up for intensive care.
The use of PCA (patient controlled analgesia) device is available in both groups.In post-operative period, magnesium infusion will be continued for 12 h. Only 100cc isotonic will be given without using magnesium to the other group. VAS (visual analog scale) score will be recorded at postoperative 30. minutes and 2,6,12,18,24 hours. In routine administration, the patient should be given 2 mg of morphine if vas>4 and the maximum dose will be increased to 10 mg.
Detailed description
After the approval of the ethics committee for the study, in the Istanbul University Faculty of Medicine Orthopedics and Traumatology Department; There will be 3 or more posterior instrumentation operations, cobb angle of 40 degrees and above, 18-75 years old, ASA (American Society of Anesthesiologists) score 1-3, no chronic neuropathic pain and no psychiatric illness, no chronic narcotic analgesics and / or substance abuse a creatine value below 1.3 will be included.
Standard anesthesia monitoring will be performed for patients taken to the operation room. Routine anesthesia induction will be performed. In the prone position, anesthesia maintenance will be provided using the infusion of propofol and remifentanil.
Our clinic; PCA (patient-controlled analgesia) device with intravenous morphine is used routinely for postoperative analgesia.In this study ;two randomized groups will be created. It will give iv magnesium(in the intraoperative period at a dose of 40mg / kg, within 30 minutes after induction) to a blindly designated group. The other group will be given only isotonic. After in post-operative period, magnesium infusion will be continued for 12 hours (40mg / kg). Magnesium sulfate will be given in 100 cc isotonic. In the other group, only 100cc isotonic will be given without using magnesium. All patients will be awakened after the analgesic agents (0,1mg / kg morphine, 15mg / kg paracetamol, nsaid) are used in routine practice and will be followed up for intensive care.
The use of PCA device is available in both groups. vas score will be recorded postoperative 30. minutes and 2,6,12,18,24 hours. In routine administration, the patient should be given 2 mg of morphine if vas>4 and the maximum dose will be increased to 10 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium | Active comparator | Drug: Magnesiumparticipations will be given intravenous magnesium. |
| control | Placebo comparator | Drug: Isotonicparticipations will be given intravenous isotonic. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 -75 years old
- Patients with posterior instrumentation surgery of 3 or more levels under general anesthesia with a cobb angle of 40 degrees and above
- Patients who will be awakened after the surgery is completed and intensive care follow-up
- Patients with ASA classification 1-3
- Patients with creatine value <1.3 g / dl
Key exclusion criteria (7 listed)
- Having a history of chronic neuropathic pain
- Having a psychiatric illness
- Patients who should not be awakened after surgery but should be followed up intubated and sedated
- Patients who cannot provide adequate cooperation for scoring
- Patients with chronic opioid use and / or substance use
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 |
|---|---|---|
| MagnesiumAlso: NMDA (n-metil d aspartat) blocker40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h) | Drug | magnesium |
| IsotonicAlso: Saline100 ml | Drug | control |
Primary outcome
morphine consumption
Time frame: 24 hours
Cumulative morphine consumption during the first 24 postoperative hours measured by patient-controlled analgesia (PCA)
1 secondary outcome
VAS score
Time frame: 24 hours
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 Jun 2026.
- Background: PubMed 24635528Jabbour HJ, Naccache NM, Jawish RJ, Abou Zeid HA, Jabbour KB, Rabbaa-Khabbaz LG, Ghanem IB, Yazbeck PH. Ketamine and magnesium association reduces morphine consumption after scoliosis surgery: prospective randomised double-blind study. Acta Anaesthesiol Scand. 2014 May;58(5):572-9. doi: 10.1111/aas.12304. Epub 2014 Mar 17.
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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.
Mehmet Ilke Buget principal investigator
Istanbul University
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 and Isotonic in people with Analgesia and Postoperative Pain, run by Istanbul University 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 5 inclusion and 7 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 Jun 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. Some participants in this study may receive a placebo. 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?
morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603638, which also lists 1 linked publication.
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 Jun 2026.