comparison of effect of local injection of Lidocaine 2% before and after incision on surgical site pain in patient undergo Lumbar Discectomy
Design
clinical trial with Control group, with parallel group, single-blinded and without randomization
Settings and conduct
interventions is done in Imam Ali (pbuh) hospital located in Bojnurd. patients is divided between two intervention groups and a control group. In first intervention group local analgesic injection will be made before skin incision. In second intervention group local analgesic injection will be made before skin incision. in control receive routine care without any local analgesic injection. patients and care takers dont have any information about groups allocation.
Participants/Inclusion and exclusion criteria
inclusion criteria: decision of surgical treatment for lumbar discopathy, no history of spinal cord surgery, no history of liver, Kidney and Thyroid diseases, weight between 50 to 80 kilograms, no history of addiction
exclusion criteria: Discectomy surgery time lasted over 1 hour, Post anesthesia recovery time lasted over 45 minutes
Intervention groups
First intervention group an injection with Lidocaine 2%, 4 mg per kg (diluted with distilled water to make 30 ml solution) before 5 minutes before skin incision will be made. injection will be made in the muscles of Lumbar Discectomy ( per-cutaneous injection in 12, 3, 6 and 9 o'clock positions).
In second intervention group an injection with Lidocaine 2%, 4 mg per kg (diluted with distilled water to make 30 ml solution) after 5 minutes after skin incision will be made. injection will be made in the muscles of Lumbar Discectomy ( per-cutaneous injection in 12, 3, 6 and 9 o'clock positions). control group don't have any injection and they will receive routine care.
Main outcome variables
postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150930024277N3
Registration date:2020-02-17, 1398/11/28
Registration timing:retrospective
Last update:2020-02-17, 1398/11/28
Update count:0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
Mehdi Pakbaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7096
Email address
ma.pakbaz@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison Between Preincisional and Intraoperative Lidocaine Infiltration and Postincisional's surgical Pain in patients undergo Discectomy surgery
Public title
Effect of local Lidocaine on Discectomy postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergo Lumbar Discectomy
patients weight between 50 to 80 Kilograms
Exclusion criteria:
History of spinal cord surgery
Liver, Kidney and Thyroid diseases
History of addiction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and the ِData Analyzer are Blind to the Study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Dolat Blvd.
City
Bojnurd
Province
North Khorasan
Postal code
7487794149
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.NKUMS.REC.1397.031
Health conditions studied
1
Description of health condition studied
herniated disk
ICD-10 code
M51.06
ICD-10 code description
Intervertebral disc disorders with myelopathy, lumbar region
Primary outcomes
1
Description
score of visual analogue scale
Timepoint
immediately, every hour for 4 hours and every 4 hours for 24 hours postoperatively.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: an injection with Lidocaine 2%, 4 mg per kg (diluted with distilled water to make 30 ml solution) before incision is made. 5 minutes before skin incision, injection is made in the muscles of place of Lumbar Discectomy ( per-cutaneous injection in 12, 3, 6 and 9 o'clock positions)
Category
Treatment - Drugs
2
Description
Intervention group: an injection with Lidocaine 2%, 4 mg per kg (diluted with distilled water to make 30 ml solution) after incision is made. 5 minutes after skin incision, injection is made in the muscles of place of Lumbar Discectomy ( per-cutaneous injection in 12, 3, 6 and 9 o'clock positions)
Category
Treatment - Drugs
3
Description
Control group: without any analgesic medicine injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali (pbuh) Hospital - Bojnurd
Full name of responsible person
Sepideh Gholami
Street address
Shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 7010
Email
Imam@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Sepideh Gholami
Street address
Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7182
Email
research@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Sepideh Gholami
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Surgical Technology
Street address
Shahriar street
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Email
sepidgholami1368@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Farhad Rahbarian Yazdi
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Dolat Blvd.
City
Bojnurd
Province
North Khorasan
Postal code
7487794149
Phone
0098583151
Email
dr.rahbarian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mehdi Pakbaz
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Email
Mehdi_pakbaz@live.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of data related to variables will be shared
When the data will become available and for how long
Six months after publish
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Be part of an academic institution
From where data/document is obtainable
Contact Mrs. Sepideh Gholami by Email: sepidgholami1368@gmail.com
What processes are involved for a request to access data/document