| CTRI Number |
CTRI/2024/07/070170 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lumbar epidural procedure and ultrasound: Predictive factors |
|
Scientific Title of Study
|
Measurement of Inter-Laminar space using ultrasound for the prediction of ease of lumbar epidural procedure : A cross sectional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rithu Rachel George |
| Designation |
Junior resident |
| Affiliation |
Sakra world hospital |
| Address |
Department of Anaesthesiology, OT complex, 2ND floor, Sakra World Hospital, Devarabeesanahalli, outer ring road,
Marathahalli,
Bengaluru,
Karnataka.
Bangalore KARNATAKA 560103 India |
| Phone |
7736438759 |
| Fax |
|
| Email |
rithugeorge2010@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dhananjay DN |
| Designation |
Senior Consultant |
| Affiliation |
Sakra world hospital |
| Address |
2ND floor, OT complex, Department of Anaesthesiology, Sakra world hospital, Devarabeesanahalli, Outer ring road,
Marathahalli
Bengaluru
Karnataka.
Bangalore KARNATAKA 560103 India |
| Phone |
8073687393 |
| Fax |
|
| Email |
dhananjaydn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dhananjay DN |
| Designation |
Senior Consultant |
| Affiliation |
Sakra world hospital |
| Address |
Department of Anaesthesiology, OT complex, 2ND floor, Sakra World Hospital, Devarabeesanahalli, Outer ring road,
Marathahalli,
Bengaluru,
Karnataka.
Bangalore KARNATAKA 560103 India |
| Phone |
8073687393 |
| Fax |
|
| Email |
dhananjaydn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, OT complex, 2ND floor, Sakra World Hospital, Devarabeesanahalli, outer ring road,
Marathahalli,
Bengaluru,
Karnataka, India,560103 |
|
|
Primary Sponsor
|
| Name |
Dr Rithu Rachel George |
| Address |
Department of Anaesthesiology, OT complex, 2ND floo, Sakra World Hospital, Devarabeesanahalli, outer ring road,
Marathahalli,
Bengaluru,
Karnataka, India, 560103 |
| Type of Sponsor |
Other [Self] |
|
|
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 Dhananjay DN |
Sakra World Hospital |
Department of Anaesthesiology, OT complex, 2ND floo, Sakra World Hospital, Devarabeesanahalli, outer ring road,
Marathahalli,
Bengaluru,
Karnataka, India, 560103 Bangalore KARNATAKA |
08073687393
dhananjaydn@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sakra World Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lumbar epidural/combined spinal epidural procedure. |
|
| ExclusionCriteria |
| Details |
Patients who deny informed consent
Patients with history of lumbar spine surgery
Allergy to local anaesthetics
Coagulation abnormalities
Suspected infection at local site
Ankylosing spondylitis
Emergency surgeries
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation of interlaminar distance measured using ULTRASONOGRAPHY in predicting the ease of epidural space identification and success of epidural catheterization in lumbar space |
Immediately after insertion of epidural catheter. Baseline and endpoint time is 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of passes.
2.Assessment of patient’s comfort during epidural procedure.
3.Assessment of pain scores during the procedure.
4.Incidence of adverse events.
|
1.Number of passes - during the procedure.
2.Other outcomes - immediately after the insertion of epidural catheter.
|
|
|
Target Sample Size
|
Total Sample Size="224" Sample Size from India="224"
Final Enrollment numbers achieved (Total)= "225"
Final Enrollment numbers achieved (India)="225" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Epidural anaesthesia is anaesthesia obtained by blocking spinal nerves in the epidural space as the nerves emerge from the dura and then pass into the intervertebral foramina. In 1885, corning performed first epidural anaesthesia with cocaine for relief of pain in an extremity, it was apparently accidental. In 1895, cathelin used epidural anaesthesia in sacral region which is now called as caudal analgesia. In 1921, F. Pages performed epidural anaesthesia in his surgical practice. In 1949, Curbelo first performed continuous epidural anaesthesia by means of ureteral catheter. Epidural anaesthesia is used to provide effective intraoperative and post operative analgesia. A segmental block is produced chiefly of spinal sensory and sympathetic nerve fibers. Motor fibers may be partially blocked. Standard epidural catheterization techniques namely the loss of resistance and saline drop methods rely on palpation of surface anatomy and the experience of the anaesthesiologist. Ultrasound assisted CSE anaesthesia technique provides improved precision and efficacy,overcoming the technical difficulties of performing neuraxial blocks. In 2001,Grau et all reported that preprocedure ultrasonography reduced the number of puncture attempts needed to establish epidural analgesia in women with risk factors for difficult neuraxial block insertion.There is significant evidence supporting the role of neuraxial ultrasound in improving the precision and efficacy of neuraxial anesthetic techniques. Multiple CNB attempts in difficult epidural procedures increase morbidities such as trauma, pain, higher incidence of post-dural puncture headache, paresthesia, spinal hematoma and failure. A five point score was created to predict DEP but there is no evidence of USG based parameter for prediction of ease of epidural procedures. The working space for the epidural procedure between two adjacent vertebrae can be divided into the interspinous and interlaminar spaces. The interlaminar space is bounded by the bases of the spinous processes, laminae, inferior articular processes, and superior articular processes. Interlaminar space can be identified and measured easily using USG due to its anatomical advantage.Information regarding USG assisted epidural insertion using interlaminar space measurement for prediction of ease of epidural procedure is minimal/nil in literature. Hence, we propose to measure the interlaminar distance using USG to find its correlation with ease of epidural. |