Effect of normal saline injection in median nerve epineurium during carpal tunnel syndrome release surgery
Design
A total of 100 patients who have the inclusion criteria will be randomly divided into intervention and control groups using a table of random numbers. The trial will be non-blinded, randomized, and in parallel groups.
Settings and conduct
In this clinical trial study, patients referred to Tabriz Imam Reza (AS) Hospital, will be candidates for surgery with the initial diagnosis of unilateral CTS (based on clinical examination and findings of electromyography and nerve conduction velocity) will be studied into two groups. The control group will undergo routine carpal tunnel release, and the intervention group will undergo normal saline injection into the endoneurium along with carpal tunnel release. Patients will be compared in terms of function and change of symptoms during discharge, a month after discharge, and 3,6 &12 months after surgery.
Participants/Inclusion and exclusion criteria
All patients with CTS who are candidates for surgery and are willing to participate in the study will enter the trial. Patients with bilateral symptoms, underlying disease, radiculopathy, and a history of surgery and fracture will not be included in the study.
Intervention groups
All patients are candidates for surgery and the surgical technique in all patients will be minimally invasive surgery. The common treatment will be performed in the control group. In the intervention group, after the release of the median nerve, a small amount of normal saline will be injected into the epineurium and the effect of this method will be compared and evaluated on follow-ups after surgery.
Main outcome variables
Patient performance status; Pain rate; The extent of neurological symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210912052451N1
Registration date:2021-10-13, 1400/07/21
Registration timing:prospective
Last update:2021-10-13, 1400/07/21
Update count:0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
Fardad Masoumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 8219
Email address
masoumi.fardad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of normal saline injection in medial nerve epithelium during carpal tunnel syndrome surgery
Public title
The effect of normal saline injection in medial nerve epithelium during carpal tunnel syndrome surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of CTS in the EMG-NCV in the initial examination
candidate for surgery
Participant's satisfaction
Exclusion criteria:
Bilateral CTS
History of surgery and fracture in wrist
Co-morbidities like diabetes or thyroid disease that exacerbates CTS
Abnormalities and deformities of the wrist
Radiculopathy
Damage to other arteries such as radial and ulnar
Elbow injuries and etc
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the very high prevalence of the disease, patients will be randomly divided into two intervention groups (normal saline injection into endonorium) and the control group (routine surgery without saline injection) using a random number table. Depending on the sample size, which is 100, a 3-digit code will be considered for each sample. Randomization will then be applied using the Rand Company table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
During discharge, one, 3, 6 and 12 months after surgery
Method of measurement
This variable will be measured based on clinical examinations and disabilities of the arm shoulder and hand score scale (DASH).
2
Description
Pain in hand.
Timepoint
During discharge, one, 3, 6 and 12 months after surgery
Method of measurement
This variable will be measured based on clinical examinations and visual analog scale.
3
Description
Neurological symptoms.
Timepoint
During discharge, one, 3, 6 and 12 months after surgery
Method of measurement
This variable will be measured based on clinical examinations.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after the release of the median nerve with minimally invasive carpal tunnel release technique , 0.5 cc of normal saline(commonly used as a sterile 9 g of salt per litre (0.9%) solution) will be injected into the nerve endoneurium with an insulin syringe( 31–29 gauge). Other surgical procedures, according to the usual technique, will be minimally invasive.
Category
Treatment - Surgery
2
Description
Control group: Routine minimally invasive surgery to median nerve release in the carpal tunnel will be performed.