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The Comparison of Analgesia Methods Used for Spinal Surgery

The Comparison of Analgesia Methods Used for Spinal Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04603638
Enrollment
82
Registered
2020-10-27
Start date
2020-10-04
Completion date
2025-02-14
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Postoperative Pain

Keywords

magnesium, morphine, scoliosis

Brief 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 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.

Interventions

DRUGMagnesium

40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h)

100 ml

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
morphine consumption24 hoursCumulative morphine consumption during the first 24 postoperative hours measured by patient-controlled analgesia (PCA)

Secondary

MeasureTime frameDescription
VAS score24 hoursPostoperative pain intensity assessed using the Visual Analog Scale (VAS, 0-10)

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORMehmet Ilke Buget

Istanbul University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026