The comparison of the effects of intaoperative injection of Methyl prednisolone,Morphine sulphate and Bupivacaine on patients' post-operative pain after lumbar discectomy
The effects of intaoperative injection of Methyl prednisolone,Morphine sulphate and Bupivacaine on patients' post-operative pain after lumbar discectomy
Design
This is a randomized clinical trial consisting of 5 groups including control group, one side blinded which will be performed on 150 patients at phase 3. The simple randomization method will be used individually for each patient.
Settings and conduct
This study will be performed in Imam Khomeini Hospital in Tehran and patients will receive medications at the end of surgery. Due to the fact that methylprednisolone has a special color, it is not possible for the physician to be blind the drug and the study will be one-sided blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients based on MRI diagnosed as intervertebral disc herniation (L4-L5 or L5-S1) who are candidates for open discectomy according to the attending physician's opinion. Exclusion criteria: patients aged below 18 and more than 65; addiction to opioids; known allergy to corticosteroids, morphins and bupivacaine; history of spine surgery.
Intervention groups
1- Patients who use 40 mg of methylprednisolone on their epidural space. 2- Patients who use 5 mg of morphine sulfate (soakd to a gelfoam) on their epidural space 3- Patients who receive 20 cc of bupivacaine as infiltrated into the paraspinal muscles and around the wound. 4- Patients who use 40 mg of methylprednisolone and 5 mg of morphine sulfate on the epidural space during surgery, and 20 cc bupivacaine are infiltrated into their paraspinal muscles and around the wound. 5- The control group in which gelfoam impregnated with normal saline is used in the epidural space and 20 cc of normal saline is infiltrated in the paraspinal muscles and around the wound.
Main outcome variables
Pain after surgery; Number of needed intravenous opioids
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210815052193N1
Registration date:2022-05-02, 1401/02/12
Registration timing:prospective
Last update:2022-05-02, 1401/02/12
Update count:0
Registration date
2022-05-02, 1401/02/12
Registrant information
Name
Mohamad Namvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3262 5238
Email address
mohamad.namvar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of intaoperative injection of Methyl prednisolone,Morphine sulphate and Bupivacaine on patients' post-operative pain after lumbar discectomy
Public title
Effect of Methyl prednisolone, Morphine sulphate and Bupivacaine on post operation back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients based on MRI diagnosed as intervertebral disc herniation (L4-L5 or L5-S1) who are candidates for open discectomy according to attending physician opinion
Exclusion criteria:
patients aged below 18 and more than 65
Addiction to opioids
known allergy to corticosteroids, morphins and bupivacaine
History of spine surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the simple randomization method will be used individually for each patient. we will put enough cards (as patients) named as groups numbers in an envelope. Each patient who is eligible to enter to the study will be assigned to a group by chance as each card comes out of the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients participating in the study will be blind about their group and the type of injected drugs. Due to the fact that one of the drugs has a special color, so it is not possible to keep the physician and researcher blind
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital, Baqer khan st
City
Tehran
Province
Tehran
Postal code
5651694774
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.236
Health conditions studied
1
Description of health condition studied
Low back pain after lumbar discectomy
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Severity of back pain after lumbar discectomy
Timepoint
At 3, 6, 12, 24 hours
Method of measurement
visual analogue score questionnaire
Secondary outcomes
1
Description
Number of needed intravenous opioids
Timepoint
24 hours after surgery
Method of measurement
Number of injected times by nurse
Intervention groups
1
Description
Intervention group: Patients who use 40 mg of methylprednisolone on their epidural space
Category
Treatment - Drugs
2
Description
Intervention group: Patients who use 5 mg of morphine sulfate (soakd to a gelfoam) on their epidural space
Category
Treatment - Drugs
3
Description
Intervention group: Patients who receive 20 cc of bupivacaine as infiltrated into the paraspinal muscles and around the woun
Category
Treatment - Drugs
4
Description
Intervention group: Patients who use 40 mg of methylprednisolone and 5 mg of morphine sulfate on the epidural space during surgery, and 20 cc bupivacaine are infiltrated into their paraspinal muscles and around the wound
Category
Treatment - Drugs
5
Description
Control group: The control group in which gelfoam impregnated with normal saline is used in the epidural space and 20 cc of normal saline is infiltrated in the paraspinal muscles and around the wound.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mohamad Namvar
Street address
Imam Khomeini Hospital, Baqer khan St
City
Tehran
Province
Tehran
Postal code
5651694775
Phone
+98 21 6119 2634
Email
mohamad.namvar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of research
Street address
Baqer khan St
City
Tehran
Province
Tehran
Postal code
5651694774
Phone
+98 21 6119 2634
Email
mohamad.namvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Namvar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Baqer khan
City
Tehran
Province
Tehran
Postal code
5651694774
Phone
+98 21 6119 2634
Email
mohamad.namvar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Namvar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Baqer khan
City
Tehran
Province
Tehran
Postal code
5651694774
Phone
+98 21 6119 2634
Email
mohamad.namvar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Namvar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Baqer khan
City
Tehran
Province
Tehran
Postal code
5651694774
Phone
+98 21 6119 2634
Email
mohamad.namvar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Data related to outcomes of the intervention would be shared
When the data will become available and for how long
1 year after publication of resuls
To whom data/document is available
Valid researchers
Under which criteria data/document could be used
for research purposes
From where data/document is obtainable
Mohamad Namvar
What processes are involved for a request to access data/document
Email sending and assessing the request in ethics committee