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The Comparison of Analgesia Methods Used for Spinal Surgery

Primary Purpose

Analgesia, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Magnesium
Isotonic
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring magnesium, morphine, scoliosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

magnesium

control

Arm Description

participations will be given intravenous magnesium.

participations will be given intravenous isotonic.

Outcomes

Primary Outcome Measures

morphine consumption
The analgesia methods will be compared with morphine consumption
VAS score
The analgesia methods will be compared with VAS score

Secondary Outcome Measures

Full Information

First Posted
August 9, 2020
Last Updated
October 25, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04603638
Brief Title
The Comparison of Analgesia Methods Used for Spinal Surgery
Official Title
The Comparison of Analgesia Methods Used for Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
July 4, 2021 (Anticipated)
Study Completion Date
February 4, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Postoperative Pain
Keywords
magnesium, morphine, scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magnesium
Arm Type
Active Comparator
Arm Description
participations will be given intravenous magnesium.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
participations will be given intravenous isotonic.
Intervention Type
Drug
Intervention Name(s)
Magnesium
Other Intervention Name(s)
NMDA (n-metil d aspartat) blocker
Intervention Description
40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h)
Intervention Type
Drug
Intervention Name(s)
Isotonic
Other Intervention Name(s)
Saline
Intervention Description
100 ml
Primary Outcome Measure Information:
Title
morphine consumption
Description
The analgesia methods will be compared with morphine consumption
Time Frame
24 hours
Title
VAS score
Description
The analgesia methods will be compared with VAS score
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek HUNDUR
Phone
+905367044679
Email
dilekhundur@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Ilke Buget
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilek HUNDUR
Phone
+905367044679
Email
dilekhundur@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24635528
Citation
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.
Results Reference
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The Comparison of Analgesia Methods Used for Spinal Surgery

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