Determine the effect of Oxiplex gel on pain relief and associated symptoms after a bilateral lumbar discectomy
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 30.
Settings and conduct
In this research, all patients referred to the Hazrat Rasoul Akram Hospital, who candidates for a bilateral lumbar diskectomy will be enrolled. Patients will be randomly divided into two groups based on 6 blocks. A total of 60 patients will be examined. Patients and data analyzers will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to Rasoul Akram Hospital, who suffered from lumbar disc herniation, will be enrolled. Inclusion criteria: All patients who will candidates for a bilateral lumbar diskectomy based on clinical signs and imaging, Patients over 18 years old. Exclusion criteria: Patients over 70 years old, Patients corticosterone recipients during the four weeks prior to surgery, Patients with intervertebral hole stenosis
Intervention groups
In the intervention group, patients will receive a 3-cc oxylex gel to cover the site during a discectomy for a single time, and in control group patients do not receive gel treatment during a discectomy.
Main outcome variables
Low back pain, Referral pain from lower back to lower limb, Score of conflict due to the disease and the reduction performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171124037606N1
Registration date:2019-01-12, 1397/10/22
Registration timing:prospective
Last update:2019-01-12, 1397/10/22
Update count:0
Registration date
2019-01-12, 1397/10/22
Registrant information
Name
Alireza Tabibkhooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2228
Email address
tabibkhooei.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine the effect of Oxiplex gel on pain relief and related symptoms after bilateral lumbar discectomy
Public title
Determine the effect of Oxiplex gel after discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who will candidates for a bilateral lumbar diskectomy based on clinical signs and imaging
Patients over 18 years old
Exclusion criteria:
Patients over 70 years old
Patients corticosterone recipients during the four weeks prior to surgery
Patients with intervertebral hole stenosis
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 6 person. In each block, 3 individuals will be in intervention group and 3 will be in control group. A total of 10 blocks will be considered for sample size.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Data will be analyzed by person who is blind to study groups. Patients and Surgeon will also be unaware of the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-12-25, 1396/10/04
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9211255001
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
S33.0
ICD-10 code description
Traumatic rupture of lumbar intervertebral disc
Primary outcomes
1
Description
Low back pain
Timepoint
Preoperatively, the next day after the operation, one month three months and six months after the operation
Method of measurement
From 1 to 10 (Based on numerical scale).
2
Description
Referral pain from lower back to lower limb
Timepoint
Preoperatively, the next day after the operation, one month three months and six months after the operation
Method of measurement
From 1 to 10 (Based on numerical scale).
3
Description
Score of conflict due to the disease and the reduction performance
Timepoint
Preoperatively, the next day after the operation, one month three months and six months after the operation
Method of measurement
From 1 to 10 (Based on numerical scale).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who receive a 3-cc oxylex gel to cover the site during a discectomy for a single time.
Category
Treatment - Drugs
2
Description
Control group: Patients who do not receive gel treatment during a discectomy.