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Analgesic effects of combination of preoperative intravenous magnesium sulfate and oral pregabalin on postoperative pain in patients undergoing posterior lumbar spinal fusion surgery

Protocol summary

Study aim
Assessing the analgesic effects of combination of preoperative intravenous magnesium sulfate and oral pregabalin on postoperative pain in patients undergoing posterior lumbar fusion surgery
Design
This study is a randomized, controlled, double-blind, four-arm parallel group, placebo-controlled phase 3 trial on 80 patients.
Settings and conduct
This study includes 80 patients undergoing posterior lumbar spinal fusion surgery. Randomization and concealment will be carried out using sealed opaque envelope. Patients will be assessed in terms of the study outcomes in 0, 4, 8, 12, 24, 48 hours postoperatively.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes patients between the ages of 18 and 70 years and patients undergoing posterior lumbar spinal fusion surgery. Exclusion criteria involves patients with hepatic dysfunction (transaminases above normal levels) and renal failure (creatinine >150 μmol/l); cardiac dysfunction (ejection fraction <40); neurological disorder, myopathy, or history of psychological disorder (e.g. current treatment with antipsychotic and antidepressant medications); known sensitivity or contraindication to dugs used in the study; preoperative opioid use or regular opioid use due to chronic pain (pain more than 3 months); preoperative administration of calcium channel blocker; hypermagnesemia.
Intervention groups
Patients in the present study will be randomly assigned to four groups including preoperative intravenous (IV) magnesium sulfate and oral pregabalin (MP) group, preoperative IV magnesium sulfate (M) group, preoperative oral pregabalin (P), and control (C) group which receives the placebo.
Main outcome variables
Primary outcome of the study is cumulative morphine consumption (mg). Secondary outcomes include visual analogue scale (VAS, 0-10) for pain at rest, Ramsay sedation scale (RSS), and postoperative nausea and vomiting (PONV).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190703044091N1
Registration date: 2020-09-14, 1399/06/24
Registration timing: prospective

Last update: 2020-09-14, 1399/06/24
Update count: 0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
Roozbeh Tavanaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 1022
Email address
rtavanaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-19, 1399/06/29
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effects of combination of preoperative intravenous magnesium sulfate and oral pregabalin on postoperative pain in patients undergoing posterior lumbar spinal fusion surgery
Public title
Effects of magnesium sulfate and pregabalin on postoperative pain in posterior lumbar spinal fusion surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 18 and 70 years Patients undergoing posterior lumbar spinal fusion surgery
Exclusion criteria:
Patients with hepatic dysfunction (transaminases above normal levels) and renal failure (creatinine >150 μmol/l) Cardiac dysfunction (ejection fraction <40) Neurological disorder, myopathy, or history of psychological disorder (e.g. current treatment with antipsychotic and antidepressant medications) Known sensitivity or contraindication to dugs used in the study Preoperative opioid use or regular opioid use due to chronic pain (pain more than 3 months) Preoperative administration of calcium channel blocker Hypermagnesemia
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in the present study will be randomized using the sealed opaque envelope. All patients, investigators, outcome assessors, and medical staff, in the present study will be blinded to the study intervention. Study drugs and placebo will be indistinguishable during the course of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients, investigators, outcome assessors, and medical staff, in the present study will be blinded to the study intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shohada-e-Tajrish Hospital, Qods Sq., Tajrish, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.474

Health conditions studied

1

Description of health condition studied
Fusion of spine, lumbar region
ICD-10 code
M43.26
ICD-10 code description
Fusion of spine, lumbar region

Primary outcomes

1

Description
Comulative morphine consumption
Timepoint
Baseline (before the operation), 4, 8, 12, 24 hours postoperatively
Method of measurement
Cumulative morphine consumption by assessing the patient controlled analgesia (PCA) pump

Secondary outcomes

1

Description
Visual analogue scale (VAS, 0-10) for pain at rest
Timepoint
Baseline (before the operation), 4, 8, 12, 24 hours postoperatively
Method of measurement
Visual analogue scale

2

Description
Posoperative nausea and vomiting (PONV)
Timepoint
In 24 hours postoperatively
Method of measurement
Number of episodes patient experiencing nausea and vomiting

3

Description
Ramsay sedation scale (RSS)
Timepoint
Baseline (before the operation), 4, 8, 12, 24 hours postoperatively
Method of measurement
Patients will be divided into 6 groups according to their level of sedation (from severe agitation to deep coma)

Intervention groups

1

Description
Intervention group 1: Patients in this group (MP) will receive preoperative intravenous infusion of 50 mg/kg magnesium sulfate mixed with 200 ml of normal saline and 300 mg pregabalin orally. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes.
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients in this group (M) will receive preoperative intravenous infusion of 50 mg/kg magnesium sulfate mixed with 200 ml and a placebo capsule. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes.
Category
Treatment - Drugs

3

Description
Intervention group 3: Patients in this group (P) will receive preoperative intravenous infusion of 200 ml of normal saline and 300 mg pregabalin orally. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes.
Category
Treatment - Drugs

4

Description
Control group: Patients in this group (C) will receive preoperative intravenous infusion of 200 ml of normal saline and a placebo capsule. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-e Tajrish hospital
Full name of responsible person
Saeed Oraee-Yazdani
Street address
Shohada-e-Tajrish Hospital, Qods Sq., Tajrish, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Email
saeed_o_yazdani@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBMUS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2270 1022
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh Tavanaei
Position
Research associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Fax
Email
rtavanaei@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Oraee-Yazdani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Fax
Email
saeed_o_yazdani@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadhosein Akhlaghpasand
Position
Research associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
19899 , Shahrdari St, Tehran, Tehran Province, Iran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Fax
Email
akhlaghpasandm@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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