Evaluation of the effect of intraoperative dexamethasone injection on symptoms of the disease and EMG-NCV in carpal tunnel release surgery
Design
50 Patients who come to yazd's Shahid Rahnemoon clinic, Khatam Alanbia clinic and Baghaiee poor clinic and present with paresthesis or prick sensation or pain in first second and third hand fingers are suspected to have carpal tunnel syndrome. then they are evaluated by EMG-NCV. The diagnosis is made by delay in distal motor reaction by 4.5 ms and sensory nerve conduction velocity of more than 3.5 ms and have the inclusion criteria are entered the study and divided into 2 groups by the order of their referral by a previously made randomization chart . the surgeon is informed about which patient belongs to which group. In one group the carpal tunnel release surgery is done alone and in the other group during the similar surgery an intraoperative dexamethasone injection is done too.
Settings and conduct
This study is done in yazd's shahid sadoohi and shahid rahnemoon hospitals. this is a double-blinded design study.the patient and the center taking the EMG-NCV records and the colleague gathering the information of the questionnarie from patients are blinded to which patient belongs to which group.
Participants/Inclusion and exclusion criteria
Inclusion criteria : No history of previous major trauma to the wrist; No history of previous carpal tunnel surgery of the hand; Age of less than 65 and more than 25; controlled diabetes; No history of known autoimmune or collagen vascular disease in patient; symptoms of less than 2 years; No history of recent systemic corticosteroid consumption.
Exclusion criteria : Median nerve pathologic findings during surgery
Intervention groups
The surgery begins with a volar 4cm longitudinal incision distal to the distal skin crease of wrist in line with the third web space, then the transverse carpal ligament and 2 cm of distal antebrachial fascia is incised then the floor of the carpal tunnel and the median nerve is explored for other possible pathologies. The different step in two groups is at this time that in the injection group Just before suturing the skin one milli-litter of dexamethasone is injected in flexor tendon sheath and inside the borders of transverse carpal ligament incision and around the median nerve but not inside the nerve. the only difference between the two groups is the injection step that in one group it is done while in the other it is not done.
Main outcome variables
If the symptom resolution and EMG-NCV results are better in the injection group we may be able to higher the satisfaction of patients from the surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171113037432N1
Registration date:2018-01-02, 1396/10/12
Registration timing:retrospective
Last update:2018-01-02, 1396/10/12
Update count:0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
mohammad motaghii
Name of organization / entity
shahid sadooghi yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4301
Email address
m.zaremehrjardi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
khatam alanbia EMG-NCV institution of yazd
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-02-18, 1395/11/30
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
empty
Scientific title
The Effect of intraoperative local Dexamethasone injection in carpal tunnel release on symptoms and EMG-NCV.
Public title
The effect of corticosteroid injection in carpal tunnel syndrom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who come to Yazd's Shahid Rahnemoon clinic, Khatam Alanbia clinic and Baghaiee poor clinic who are suspected to have carpal tunnel syndrome by symptoms. then they are diagnosed by delay in distal motor reaction by 4.5 ms and sensory nerve conduction velocity of more than 3.5 ms in EMG-NCV.
Age of less than 65 and more than 25
Doesn't have known autoimmune or collagen vascular disease
Symptoms of no more than 2 years
No history of recent systemic corticosteroid consumption
Exclusion criteria:
median nerve pathologic condition encountered during surgery
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
randomization was based on a computer randomized number chart. each patient was granted a randomized number due to order of referral. the number specifies which group it belongs to.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded design study.the patient and the center taking the EMG-NCV records and the colleague gathering the information of the questionnarie from patients are blinded to which patient belongs to which group.
Placebo
Not used
Assignment
Parallel
Other design features
none
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid sadooghi university of medical sciences of yazd
Street address
yazd, alam square
City
yazd
Province
Yazd
Postal code
8915173149
Approval date
2017-10-04, 1396/07/12
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.117
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
improvement in symptoms
Timepoint
just before surgery and 2 weeks after surgery
Method of measurement
questionnarie value is the sum of nembers given to each symptom and is a integer
2
Description
EMG-NCV records for median nerve
Timepoint
first in one month before surgery and second time 3 month after surgery
Method of measurement
the time that impulse pass through nerve and is measured by milli-seconds
Secondary outcomes
empty
Intervention groups
1
Description
Control group : The surgery begins with a 4cm volar skin incision starting from distal to the distal wrist crease in line with the third web space. then transverse carpal ligament and 2cm of distal antebrachial fascia is completely incised and the median nerve is released, the median nerve and the tunnel are explored for possible pathologies, the wound is irrigated and skin is closed.
Category
Treatment - Surgery
2
Description
Intervention group : The surgery begins with a 4cm volar incision starting from distal to the distal wrist crease in line with the third web space. then transverse carpal ligament and 2cm of distal antebrachial fascia is completely incised and the median nerve is released, the median nerve and the tunnel are explored for possible pathologies and the wound is irrigated in this step 1ml of dexamethasone with 4 mili-gram in one mili-liter concentration is injected in the flexor tendon sheath and in borders of the transverse ligament cuts and spilled around the median nerve, the difference between two study groups is just in this step and other surgical steps are the same for both groups. then the skin is closed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid rahnemoon hospital
Full name of responsible person
dr. mostafa zare mehrjardi
Street address
Farokhi street, Azadi square, Yazd
City
yazd
Province
Yazd
Postal code
8913893111
Email
m.zaremehrjardi@ssu.ac.ir
2
Recruitment center
Name of recruitment center
baghaee poor clinic
Full name of responsible person
dr. mohammad motaghi
Street address
Shahid sadooghi hospital, Riazi square, Yazd
City
yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0001
Email
m.zaremehrjardi@ssu.ac.ir
3
Recruitment center
Name of recruitment center
khatam alanbia clinics
Full name of responsible person
dr. mostafa zare mehrjardi
Street address
yazd , taleghani street
City
yazd
Province
Yazd
Postal code
8913893111
Email
m.zaremehrjardi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
EMG-NCV institution of khatam alanba clinic
Full name of responsible person
dr. mostafa zare
Street address
yazd, taleghani street
City
yazd
Province
Yazd
Postal code
8913893111
Email
m.aremehrjardi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
EMG-NCV institution of khatam alanba clinic
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
shahid sadooghi univercity of medical siences
Full name of responsible person
dr. mostafa zare mehrjardi
Position
orthopaedic surgeon
Latest degree
Specialist
Other areas of specialty/work
Street address
yazd bahonar square
City
yazd
Province
Yazd
Postal code
8915173149
Phone
+353 8203410
Fax
Email
m.zaremehrjardi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid sadooghi univercity of medical siences
Full name of responsible person
dr. mostafa zare mehrjardi
Position
orthopaedic sergeon
Latest degree
Specialist
Other areas of specialty/work
Street address
Bahonar square, Yazd
City
yazd
Province
Yazd
Postal code
8915173149
Phone
+353 8202632
Fax
+98 35 3820 2632
Email
m.zaremehrjardi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shahid sadooghi univercity of medical siences
Full name of responsible person
dr. mohammad motaghi
Position
orthopaedics resident
Latest degree
Specialist
Other areas of specialty/work
Street address
yazd.bahonar square
City
yazd
Province
Yazd
Postal code
8915173149
Phone
+353 8203410
Fax
Email
mohammad_682000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available