Evaluating the effect of Bupivacaine for the purpose of analgesia in patients whom underwent lumbar spine surgery
Design
Three arms parallel clinical trial including one control group and two case groups, triple blinded study, randomized, with sample size of 90 patients (3 * 30). For randomization, the Random Allocation Software will be used.
Settings and conduct
The place for conducting the research is Shahid Madani hospital in Karaj.
The pain of patients' surgery site will be measured using Visual Analogue Scale (VAS) method and at specific times after surgery.
The patients, the physician who evaluates the pain and the analyzer won't be aware of the patients' groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years old with spinal degenerative damage who undergo lumbar spine surgery.
Exclusion criteria: No consent for participation, history of opioid addiction, any contraindication for drug infiltration, any history of allergic reaction to the drugs used in this project, chronic pain syndromes, history of seizure.
Intervention groups
1. Control group
2. Patients who receive Bupivacaine in their wounds after surgery
3. Patients who receive Bupivacaine plus Epinephrine in their wounds after surgery
Main outcome variables
VAS score for the pain of surgery site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210213050348N2
Registration date:2021-09-01, 1400/06/10
Registration timing:prospective
Last update:2021-09-01, 1400/06/10
Update count:0
Registration date
2021-09-01, 1400/06/10
Registrant information
Name
Arman Maghoul
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2276 1912
Email address
arman.maghoul@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-12, 1400/06/21
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of postoperative analgesia following wound infiltration with Bupivacaine 0.25 solution after posterior lumbar spine surgeries
Public title
Evaluation of analgesia following Bupivacaine use in spine surgeries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old whom are cases of degenerative damage to spine and undergo lumbar spine surgery.
Exclusion criteria:
No consent for being in this study.
Addiction to opioids.
Any contraindications for drug infiltration.
Any history indicative of allergic reaction to the drugs used in this study.
Chronic pain syndromes.
History of seizure.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, a number is assigned to each participant and then the numbers are evenly divided into three blocks of control, Bupivacaine and Bupivacaine-Epinephrine by Random allocation software using simple block randomization method. For this purpose, after installing the program, we determine the number of groups, the sample size and the name of each group. Then, the software places patients with different codes in different groups according to the size of the groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient won't be aware of his/her study group after signing the consent form.
The physician whom evaluates the outcome in the patient won't be present at the patient's operation and is not aware of the patient's study group.
The data will be encrypted and the analyzer won't be aware of the patients' study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethichs committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, North Taleghani Blvd. , Taleghani Sq. , Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.ABZUMS.REC.1400.002
Health conditions studied
1
Description of health condition studied
Spine degenerative damage
ICD-10 code
M51.35
ICD-10 code description
Other intervertebral disc degeneration, thoracolumbar region
Primary outcomes
1
Description
Visual Analogue Scale (VAS)score for surgical site pain
Timepoint
6, 12 and 24 hours after surgery
Method of measurement
By asking the patient to point out his/her pain degree on the VAS chart
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Bupivacaine won't be injected into these patients
Category
Treatment - Drugs
2
Description
Intervention group one: Bupivacaine. 30 cc of 0.25% Bupivacaine solution will be infiltrated into the wound of the surgery after the operation is done.
Category
Treatment - Drugs
3
Description
Intervention group two: Bupivacaine and Epinephrine. 30 cc of 0.25% Bupivacaine and 1/200000 Epinephrine (in order to induce vasospasm and prolonging the time of drug in the tissue) will be infiltrated into the wound of the surgery after the operation is done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Mohammad Kamangar
Street address
Madani Sq. , Jahanshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3143744693
Phone
+98 26 3442 7001
Email
madanihp@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Hatam Goodini
Street address
Alborz University of Medical Sciences, North Taleghani blvd., Taleghani Sq., Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Mohammad Kamangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Alborz University of Medical Sciences, North Taleghani blvd. , Taleghani Sq. , Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
dr_mkamangar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mohammad Kamangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Alborz University of Medical Sciences, North Taleghani blvd. , Taleghani Sq. , Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
dr_mkamangar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mohammad Kamangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Alborz University of Medical Sciences, North Taleghani blvd. , Taleghani Sq. , Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
dr_mkamangar@yahoo.com
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