Assessment of cycloserine effect on neuropathic pain after lumbar disc herniation surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized by table of random numbers, phase 2-3 on 68 patients.
Settings and conduct
1. Patients are selected from lumbar disc evacuation candidates in one or two spaces during 6.
2. Randomization is done.
3. Entry and exit criteria are applied.
4. Each patient receives a capsule of medicine or placebo two hours before the operation.
5.Record the amount of pain and morphine consumption at regular intervals until the end of 24 hours
May be.
6. The collected data are categorized within 24 hours.
In this study, participants, the main researcher, health care personnel (physicians, nurses) who are responsible for patient care are blind to the study.
7. This study is performed in Shahid Madani Educational and Medical Center in Karaj.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age: 24 to 19 Between BMI .2 70 to 18
3. Having informed consent 4. Adaptation of clinical signs and symptoms to imaging findings
Exclusion criteria: 1. Previous surgical intervention 2. History of alcohol or drug addiction 3. morphine complications during the study 4.
Pregnancy 5 .Breastfeeding 6 .Psychiatric illnesses such as depression 7 .Nervous illnesses such as seizures 8 .Use of antidepressants
Pain during the last 24 hours 9. Existence of internal diseases such as DM 10. Aphasia or visual impairment
Intervention groups
Control group: The whole group of patients in the control group is given a dose of capsule filled of Rice powder and the volume and weight of the drug are the same as in the intervention group. Intervention group: Cycloserine 250 g capsules are given to all members of the intervention group 2 hours before the start of surgery orally and in a single dose
Main outcome variables
1.lumbar pain
2.Morphine intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046150N1
Registration date:2020-09-12, 1399/06/22
Registration timing:retrospective
Last update:2020-09-12, 1399/06/22
Update count:0
Registration date
2020-09-12, 1399/06/22
Registrant information
Name
Pouria Basiry
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4436 8227
Email address
pouriabasiry@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of cycloserine effect on neuropathic pain after lumbar disc herniation surgery
Public title
cycloserine effect on neuropathic pain decreasing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-70 years old
BMI 19-24
Having informed consent
Adaptation of clinical signs and symptoms to imaging findings
Exclusion criteria:
Candidate patients for laminectomy discectomy
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple random method based on a single sequence of
Random allocations have been used. A table of random numbers has been used for this purpose.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants included the main researcher, health care personnel (physicians, nurses) who are responsible for patient care, and data collection officials regarding the type of drugs given to patients and also in which group each person Are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Office of the Ethics Committee, Second Floor, Deputy of Research and Technology, Saffarian Alley, 45 Golshahr Street, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2020-08-24, 1399/06/03
Ethics committee reference number
IR.ABZUMS.REC.1399.128
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
G55.1
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders
Primary outcomes
1
Description
lumbar pain
Timepoint
6,12,18,24 hours post operation
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
Morphine intake
Timepoint
6,12,18,24 hours post operation
Method of measurement
The volume of drug injected into the cc
Intervention groups
1
Description
Intervention group: Cycloserine 250 g capsules are given to all members of the intervention group 2 hours before the start of surgery orally and in a single dose.
Category
Treatment - Drugs
2
Description
Control group:The whole group of patients in the control group is given a dose of capsule filled of Rice powder and the volume and weight of the drug are the same as in the intervention group 2 hours before the start of surgery.