| CTRI Number |
CTRI/2021/03/032333 [Registered on: 26/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Other (Specify) [ULTRASOUND USE IN EPIDURAL] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
COMPARING SUCCES RATE AND ADVERSE EVENTS BETWEEN EPIDURAL ANAESTHESIA TECHNIQUE USING ULTRASOUND SCANNING AND CONVENTIONAL TECHNIQUE OF ANATOMICAL LANDMARK IN KNEE REPLACEMENT SURGERY PATIENTS |
|
Scientific Title of Study
|
COMPARISON OF EASE OF PROCEDURE AND SUCCESS
RATE IN LUMBAR EPIDURAL ANAESTHESIA USING PRE-
PROCEDURAL ULTRASOUND MARKING AND MANUAL
PALPATION TECHNIQUE IN KNEE ARTHROPLASTY
PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANOOP SEBASTIAN |
| Designation |
DNB RESIDENT |
| Affiliation |
SAKRA WORLD HOSPITAL |
| Address |
DNB RESIDENT ANAESTHESIA
SAKRA WORLD HOSPITAL
BANGALORE
Bangalore KARNATAKA 560103 India |
| Phone |
8606670866 |
| Fax |
|
| Email |
sebastian.anoop@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DHANANJAY D N |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SAKRA WORLD HOSPITAL |
| Address |
SENIOR CONSULTANT
ANAESTHESIA
SAKRA WORLD HOSPITAL
BANGALORE
Bangalore KARNATAKA 560103 India |
| Phone |
8073687393 |
| Fax |
|
| Email |
dhananjaydn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
ANOOP SEBASTIAN |
| Designation |
DNB RESIDENT |
| Affiliation |
SAKRA WORLD HOSPITAL |
| Address |
DNB RESIDENT ANAESTHESIA
SAKRA WORLD HOSPITAL
BANGALORE
KARNATAKA 560103 India |
| Phone |
8606670866 |
| Fax |
|
| Email |
sebastian.anoop@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAKRA WORLD HOSPITAL
BANGALORE |
|
|
Primary Sponsor
|
| Name |
SAKRA WORLD HOSPITAL |
| Address |
SAKRA WORLD HOSPITAL
BANGALORE |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 ANOOP SEBASTIAN |
SAKRA WORLD HOSPITAL |
DEVARABEESANAHALLI
VARTHUR HOBLI
BANGALORE Bangalore KARNATAKA |
8606670866
sebastian.anoop@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TRADITIONAL MANUAL PALPATION TECHNIQUE |
NIL |
| Intervention |
USE OF ULTRASOUND |
ULTRASOUND TO IDENTIFY EPIDURAL SPACE AND COMPARED WITH TRADITIONAL MANUAL ALPATION TECHNIQUE FOR EPIDURAL ANAESTHESIA |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult’s patients of ASA 1 and 2 between 50-70 years coming for knee arthroplasty |
|
| ExclusionCriteria |
| Details |
1. No consent from the patient’s caregiver/ patients or attender’s refusal.
2. Lower limb Neuropathy in preoperative evaluation.
3. History of lower back pain.
4. Coagulation disorders
5. Hemodynamic instability in perioperative period.
6. Previous history of spine surgeries
7. History of post-Dural puncture headaches.
8. Allergy to local anaesthesia drugs (Lignocaine and Bupivacaine). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Ease of epidural insertion as assessed by
|
after epidural cathetrisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of pre-procedural epidural length determined by ultrasound with actual length identified by loss of resistance technique.
2. Comparison of comfort level felt by patient during epidural catheterization procedure.
3. Comparison of average Length of epidural space in males and females in Indian population.
4. Incidence of adverse events. |
after completion of epidural cathetrisation |
|
|
Target Sample Size
|
Total Sample Size="144" Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2021 |
| Date of Study Completion (India) |
16/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Combined spinal epidural anaesthesia is the preferred choice for anaesthesia in knee arthroplasty patients. Lumbar neuraxial procedures are typically performed via a blind surface landmark and palpation technique. The success depends on good knowledge of anatomy and skills due to its complexity. Patient factors such as obesity, abnormal spinal anatomy or previous spine surgeries result in increased failure rate of neuraxial blockade. The intercristal line/ Tuffiers line determined by palpation may not be a reliable landmark for fourth and fifth lumbar interspace in neuraxial anaesthesia. Lumbar spinous process increases significantly in both length and width with ageing, which makes epidural anaesthesia technique challenging through midline in geriatric population in whom majority of knee replacement surgeries are done. Neuraxial ultrasonography in epidural space identification is a recent development and has shown to improve the success rate of neuraxial blockade and can reduce the risk of failed or traumatic lumbar punctures and epidural catheterizations. The use of preprocedural ultrasound has been shown to increase first pass success rate in thoracic epidural catheter insertion and spinal anaesthesia in patients with difficult surface landmarks. Therefore, this prospective, randomised study has been designed to assess the ease of insertion and its success rate after identification of the relevant landmarks using ultrasound as compared to traditional palpation of bony landmarks. |