| CTRI Number |
CTRI/2021/01/030758 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
06/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of epidural catheter fixation methods |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF EFFICACY OF THREE DIFFERENT TECHNIQUES OF EPIDURAL CATHETER FIXATION: A PROSPECTIVE RANDOMISED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidarshna V |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of anaesthesiology
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Department of anaesthesiology
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056021817 |
| Fax |
|
| Email |
vid7209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sathish K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of anaesthesiology
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai
Department of anaesthesiology
Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600116
India |
| Phone |
8056046730 |
| Fax |
|
| Email |
drsathishkalyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathish K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of anaesthesiology
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai
Department of anaesthesiology
Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600116
India |
| Phone |
8056046730 |
| Fax |
|
| Email |
drsathishkalyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal Investigator |
| Sri Ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Vidarshna V |
| Address |
Department of Anaesthesiology
Sri Ramachandra Institute of Higher Education and Research |
| Type of Sponsor |
Other [Principle investigator ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidarshna V |
Sri Ramachandra Institute of Higher Education and Research |
Department of anaesthesiology
6th floor, Udayar block, theatre comple
No. 1 , Ramachandra Nagar
Porur 600116
Chennai
TAMIL NADU |
8056021817
vid7209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, (4) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (5) ICD-10 Condition: V099||Pedestrian injured in unspecifiedtransport accident, (6) ICD-10 Condition: S729||Unspecified fracture of femur, (7) ICD-10 Condition: S829||Unspecified fracture of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lockit fixator device |
The epidural catheter will be threaded through the central eyelet of Lockit fixator device, after its exit from skin. The adhesive on the Lockit device sticks on the skin and the clamp is closed over the catheter. |
| Comparator Agent |
Standard dressing |
coiled catheter at skin exit under a transparent adhesive dressing |
| Intervention |
Subcutaneous tunneling |
The epidural catheter will be subcutaneously tunneled vertically using a Tuohy 18G epidural needle 1.5 cm lateral to the midline. The epidural needle will be used to create the tunnel 3-4 cm long in subcutaneous plane, moving from above downward after local infiltration, with its lower end at the same horizontal level as the epidural puncture site. A small loop of catheter will be left between the epidural puncture site and the tunnel entry. A piece of sterile gauze will be placed under this loop. The catheter is gently pulled up to the right shoulder, and the entire length will be covered by Tegaderm. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring post operative epidural analgesia |
|
| ExclusionCriteria |
| Details |
Contraindication to neuraxial blockade
Pre-existing neurological disabilities
Significant spinal deformities
Unable to understand, express and communicate visual analog scores |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify a simple, safe and effective method of fixing the epidural catheter. |
During fixation
At end of surgery during shifting
During removal - at 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient comfort |
During catheter placement |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/02/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Epidural catheter fixation is very important. The technique of securing the epidural catheter has a major bearing on the efficacy of epidural analgesia Inward migration of the epidural catheter has been reported with intravascular, subdural or subarachnoid injection of repeat doses. Outward migration might lead to loss of analgesia and unsuccessful attempts to re-establish it. Many factors have been correlated with migration, but an appropriate fixation technique for the catheter should form the most practical way to prevent it. To identify a simple, safe, non-invasive and effective method of fixing the epidural catheter. Group S - Standard dressing Group T - Subcutaneous tunneling Group L - Lock-it fixator device Patient is followed for 24hrs and observed for analgesia adequacy and catheter migration. |