compare the role of continuous epidural method and continuous paravertebral in analgesia after knee arthroplasty
Design
Patients were randomly divided into two groups (n = 19) continuous epidural and continuous paravertebral block.Patients were completely randomly divided into four groups of continuous epidural receiving and continuous paravertebral block by Blocked Randomization method.
Using the table of random numbers and quadratic blocks, the following conditions were obtained in which group A individuals received continuous epidural and group B individuals received continuous paravertebral block. Putting four blocks together creates situations that are completely random and randomly divided patients)In order to blind and hide the samples, a special code is written for each patient in a sealed envelope, which is opened only before attempting to anesthetize the patient and only by the researcher and in complete secrecy, and informs the patient group
Settings and conduct
Recovery of the general operating room of Rasoul Hospital. In both groups, 15 mg bupivacaine injection of 0.25% was performed in L2 / 3 space and epidural and paravertebral catheters were implanted in the respective groups and finally the pain pump was connected to the catheter.To blind and hide the samples For each patient, a special code is written inside the sealed envelope, which was opened only before the patient was anesthetized
Participants/Inclusion and exclusion criteria
Admission: Physical level one and two. age 40 to 70 years. Satisfaction with the study
No entry: Allergy to any of the drugs used in the study. body mass index>40. severe liver and heart disease. addiction or prolonged use of analgesia
Intervention groups
the effectiveness of Continuous paravertebral block performed to reduce pain after knee surgery.
Main outcome variables
Pain intensity in static and dynamic posture؛mobility؛muscle strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045095N1
Registration date:2021-09-10, 1400/06/19
Registration timing:retrospective
Last update:2021-09-10, 1400/06/19
Update count:0
Registration date
2021-09-10, 1400/06/19
Registrant information
Name
sara zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4461 6943
Email address
sarazamaniaa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-18, 1398/02/28
Expected recruitment end date
2020-01-18, 1398/10/28
Actual recruitment start date
2019-08-23, 1398/06/01
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-10-22, 1399/08/01
Scientific title
Comparative study of the effect of two continuous epidural methods and continuous paravertebral block on pain after knee arthroplasty surgery
Public title
effect of continuous epidural and continuous paravertebral block on pain after knee arthroplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 40-70 years
ASA I , II
having the satisfaction of participating in the study
Exclusion criteria:
sensitivity to any of the drugs used in the study
Body mass index>40
severe liver and heart disease
addiction or prolonged use of analgesics
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
39
Actual sample size reached:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups (n = 19) continuous epidural and continuous paravertebral block.
Patients were completely randomly divided into four groups of continuous epidural receiving and continuous paravertebral block by Blocked Randomization method.
Using the table of random numbers and quadratic blocks, the following conditions were obtained in which group A individuals received continuous epidural and group B individuals received continuous paravertebral block. Putting the four blocks together results in situations that are completely random and the patients are randomly divided.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind and hide the samples for each patient, a special code is written inside the sealed envelope, which is opened only before the patient is anesthetized and only by the researcher and in complete secrecy, and informs the patient group.
Placebo
Not 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
Jam e jam hemmattower Heidari moghadam St Sardar jangal Blvd
City
Tehran
Province
Tehran
Postal code
1476661349
Approval date
2020-04-03, 1399/01/15
Ethics committee reference number
IR.IUMS.FMD.REC.1397.175
Health conditions studied
1
Description of health condition studied
Degenerative joint disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain following joint changes leading to surgery and knee replacement
Timepoint
Immediately after the intervention 4 hours after the intervention 8 hours after the intervention 16 hours after the intervention 24 hours after the intervention
Method of measurement
Pain intensity with VAS scale numbered by a ruler on a scale of 0 to 10
Secondary outcomes
1
Description
Age
Timepoint
0
Method of measurement
Year
2
Description
Sex
Timepoint
0
Method of measurement
Male or female
3
Description
Weight
Timepoint
0
Method of measurement
Different number by kilogram
4
Description
Side effects of anesthesia
Timepoint
24 hours
Method of measurement
Patient symptoms
5
Description
Side effects of mepridine
Timepoint
24 hours
Method of measurement
Patient symptoms
6
Description
Amount of mepridine
Timepoint
24 hours
Method of measurement
By used dosage
Intervention groups
1
Description
Control group: Epidural block group In this trial, our treatment method was performed to reduce pain after knee replacement surgery.10 to 15 cc bupivacaine is 0.25%, which is injected epidurally.
Category
Treatment - Drugs
2
Description
Intervention group: Paravertebral block group is used as a treatment method to reduce pain after knee joint surgery.10 to 15 cc bupivacaine is 0.25% which is injected paravertebrally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool akram hospital
Full name of responsible person
Sara zamani
Street address
Jam e jam hemmat tower . heidari moghadam st . sardar jangal blvd
City
Tehran
Province
Tehran
Postal code
1476661349
Phone
+98 21 4461 7095
Email
Sarazamaniaa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas motevalian
Street address
Next to the milad tower . hemmat highway
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8862 2675
Email
iumspr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sara zamani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Jam e jam hemmat tower . heidari moghadam st . sardar jangal blvd
City
Tehran
Province
Tehran
Postal code
1476661349
Phone
+98 21 4461 6943
Email
Sarazamaniaa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara zamani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Jam e jam hemmat tower . Heidari st . Sardar jangal blvd
City
Tehran
Province
Tehran
Postal code
1476661349
Phone
+98 21 4461 6943
Email
Sarazamaniaa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara zamani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Jam e jam hemmat tower . Heidari moghadam st . sardar jangal blvd
City
Tehran
Province
Tehran
Postal code
1476661349
Phone
+98 21 4461 6943
Email
Sarazamaniaa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD