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: Comparison of ultrasound guided saphenous nerve block and high volume proximal adductor canal block for acute postoperative pain management in patient undergoing knee surgeries

Protocol summary

Study aim
Determining the comparison between the two methods of saphenous nerve block and nerve block in the proximal adductor canal with high volume in knee surgeries to control of acute pain
Design
A double-blind controlled two-group trial after surgery in recovery if each patient has the characteristics of random entry using the last digit of the patient file number, even numbers in one group and odd numbers in the other group. Each group is 25 , total 50
Settings and conduct
Both groups take general anesthesia saphenous nerve block with sonoguided, with 0.2% ropivacaine drug with a volume of 15 cc in the middle of the thigh. the second Proximal adductor canal block of the lower third of the thigh with a sonoguide is performed with the drug ropivacaine 0.1% with a volume of 30 cc in one year in Firozgar hospital
Participants/Inclusion and exclusion criteria
Entry, All patients between 30 and 70 years old with ASA one and two undergoing Anterior cruciate ligament surgery and total knee joint replacement, tibial plateau surgery and tibial osteotomy ,Non-entry, no pain during recovery, duration of operation more than three hours, addiction to drugs, any use of painkillers within 48 hours before the operation and history of previous surgery on the same knee
Intervention groups
Nerve block or regional nerve block is any intentional interruption in the movement of the nerve message along the nerve, which is usually done in order to reduce pain, In this study these blocks are used to apply anesthesia in therapeutic interventions involving the distal thigh and femur, the knee, and the medial part of the leg.
Main outcome variables
Acute pain control based on NRS, restlessness based on Ramsay sedation score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210607051501N2
Registration date: 2024-03-18, 1402/12/28
Registration timing: prospective

Last update: 2024-03-18, 1402/12/28
Update count: 0
Registration date
2024-03-18, 1402/12/28
Registrant information
Name
Ali Khatibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8856 7458
Email address
khatibi.al@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-23, 1403/03/03
Expected recruitment end date
2026-01-18, 1404/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Comparison of ultrasound guided saphenous nerve block and high volume proximal adductor canal block for acute postoperative pain management in patient undergoing knee surgeries
Public title
Comparison of two nerve block saphenous nerve block and high volume proximal adductor canal block
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ASA 1 ASA 2 with controled systemic disease knee surgary for first time
Exclusion criteria:
ASA 3, 4 no pain in PACU surgary time more than 3 Hs Any painkiller 48 h before surgary addiction previuose surgary on the same knee
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomly using the last digit of the patient's file number.even numbers are placed in one group and odd numbers are placed in another group . Only the person performing the block knows which block is performed for each patient and placement in each category.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the same injection site (distal of femur), only the person performing the injection is aware of the type of block performed. and writes the name of each patient in its coded category,The patient himself, the questioner and the information collector and the final analyzer are unaware of which category and type of block they have received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of school of medicine, Iran University of Medical Sciences (IUMS)
Street address
School of medicine, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
IR.IUMS.FMD.REC.1402.431

Health conditions studied

1

Description of health condition studied
knee surgeries
ICD-10 code
M23.9
ICD-10 code description
Unspecified internal derangement of knee

Primary outcomes

1

Description
Pain score
Timepoint
2,4,6,12 Hs After block
Method of measurement
Numeric pain rating Scale (NRS)

2

Description
Comparison of agitation after two nerves block
Timepoint
2,4,6,12 Hs After block
Method of measurement
Ramsy Sedation Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: proximal adductor canal block in the place of the distal third of the thigh with a sono guided by 30 ml of ropivacaine 0.1 percent If there is pain after surgery, it will be done in recovery unite for the patient.
Category
Treatment - Drugs

2

Description
Intervention group2: saphenous nerve block in the upper third of the thigh with a sono guided by 15 ml of ropivacaine 0.2 percent If there is pain after surgery, it will be done in recovery unite for the patient
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Ali Khatibi
Street address
Firoozgar hospital, Behafarin st., Karimkhan-e-zand st., Vali_asr sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Fax
+98 21 8214 1600
Email
khatibi.al@iums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
khatibi.al@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
Ali Khatibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Firoozgar hospital, Behafarin st., Karimkhan-e-zand st., Vali-asr sq.
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1600
Email
khatibi.al@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Khatibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Firoozgar hospital, Behafarin st., Karimkhan-e-zand st., Vali-asr sq.
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1600
Email
khatibi.al@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Salahian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 179, West Hedary moghaddam, Mokhberi, Poonak
City
Tehran
Province
Tehran
Postal code
1476619164
Phone
+98 21 4444 3624
Email
Mehrbaran.maria@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All datas could be shared after unidentification of the participants
When the data will become available and for how long
6 months after publication
To whom data/document is available
The results and datas would be available for everybody
Under which criteria data/document could be used
No limitation
From where data/document is obtainable
The main author Dr Ali Khatibi, email address khatibi.al@iums.ac.ir
What processes are involved for a request to access data/document
Sending the request, assessment the request by the author of this study
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