| CTRI Number |
CTRI/2021/09/036465 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
IN FAT PATIENT, COMPARATIVE STUDY OF BEFORE PROCEDURE ULTRASOUND AND DURING PROCEDURE ULTRASOUND GUIDED COMBINED SPINAL EPIDURAL ANAESTHESIA. |
|
Scientific Title of Study
|
Comparative Study of Pre-procedure and Real time Ultrasound-guided Combined Spinal Epidural (CSE) Anaesthesia in Obese Patient |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAVI ANAND |
| Designation |
Fellowship Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
ANANDITA HOSPITAL , ROAD NO 13 C, RAJENDRA NAGAR, PATNA
Patna
BIHAR
800016
India |
| Phone |
7739290418 |
| Fax |
|
| Email |
drravianand75@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJ BAHADUR SINGH |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Trauma and Emergency Department, IGIMS, Patna-800014
Patna
BIHAR
800014
India |
| Phone |
7897844636 |
| Fax |
|
| Email |
virgodocraj36@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
RAVI ANAND |
| Designation |
Fellowship Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
ANANDITA HOSPITAL , ROAD NO 13 C, RAJENDRA NAGAR, PATNA
Patna
BIHAR
800016
India |
| Phone |
7739290418 |
| Fax |
|
| Email |
drravianand75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, PATNA |
| not receiving any monetary funding |
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Trauma and Emergency (Anaesthesiology)
|
| Type of Sponsor |
Government medical college |
|
|
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 RAVI ANAND |
Emergency ICU and Red Zone Area of Department of Trauma and Emergency |
Indira Gandhi Insitute of Medical Sciences, Shekhpura, Patna-800014
Patna
BIHAR |
7739290418
drravianand75@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS |
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 |
combined spinal epidural (CSE) anaesthesia
|
USG guideded combined spinal epidural (CSE) anaesthesia given to assigned group. |
| Comparator Agent |
pre procedure and real time USG guided CSE Anaesthesia |
pre procedure USG guided CSE Anaesthesia Vs real time USG guided CSE Anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 20-85 years, American Society of Anesthesiologists (ASA) grade II or III obese with body mass index (BMI) >30 kg/m2 scheduled for the elective lower abdominal, perineal and lower limb surgeries patients will be eligible. |
|
| ExclusionCriteria |
| Details |
It includes contraindications to neuraxial blocks, pregnant patients and the patient refusal for combined spinal epidural anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of attempts:
Number of passes:
|
seconds
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to achieve successful Anaesthesia |
seconds |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="77" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2021 |
| Date of Study Completion (India) |
31/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2022 |
|
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
|
prospective trial will be published only after competion of study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Combined Spinal epidural anaesthesia is generally
performed using a surface landmark-based “blind†technique. The incidences of
post-dural puncture headache, paresthesia, and spinal haematoma are directly
associated with multiple passes and attempts while administering combined spinal
epidural anaesthesia. A pre-procedural ultrasound (PUS) for neuraxial technique
has been used successfully to perform Combined Spinal epidural anaesthesia.
Information on the use of real-time ultrasound (RUS)
guided Combined Spinal epidural anaesthesia is limited and has limited to case
series and case reports and few prospective observational studies. The RUS
permits a more accurate estimation of the appropriate needle insertion site and
trajectory
AIM
The aim of this study is
to compare the efficacy of Pre-Procedure
Ultrasound and Real-time Ultrasound approach
for Combined Spinal Epidural anaesthesia. OBJECTIVE
The objective of this
study is:
1. To compare the effect of pre-procedure ultrasound and real-time ultrasound in
combined spinal epidural (CSE) anaesthesia in obese patients to perform the
elective lower abdominal, perineal and lower limb surgeries.
2. To compare the number of
attempts, number of passes, and time taken for successful lumbar puncture in
both of pre-procedure ultrasound and real-time ultrasound in combined spinal
epidural (CSE) anaesthesia
|