| CTRI Number |
CTRI/2022/11/047402 [Registered on: 17/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To see if adding saline to epidural space can cause change in effect of spinal anaesthesia |
|
Scientific Title of Study
|
To evaluate the effect of epidural volume extension with saline in combined spinal epidural for lower limb surgeries using intrathecal ropivicaine with fentanyl |
| Trial Acronym |
EVE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SIMRITA GILL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SARDAR PATEL MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PBM HOSPITAL,BIKANER
DEPARTMENT OF ANAESTHESIOLOGY,PBM HOSPITAL,BIKANER
Bikaner
RAJASTHAN
334001
India |
| Phone |
7009248350 |
| Fax |
|
| Email |
simritagill21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANITA PAREEK |
| Designation |
SENIOR PROFESSOR AND FORMER HEAD |
| Affiliation |
SARDAR PATELL MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PBM HOSPITAL,BIKANER
DEPARTMENT OF ANAESTHESIOLOGY,PBM HOSPITAL,BIKANER
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANITA PAREEK |
| Designation |
SENIOR PROFESSOR AND FORMER HEAD |
| Affiliation |
SARDAR PATELL MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PBM HOSPITAL,BIKANER
DEPARTMENT OF ANAESTHESIOLOGY,PBM HOSPITAL,BIKANER
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
|
Source of Monetary or Material Support
|
| SARDAR PATEL MEDICAL COLLEGE,BIKANER |
|
|
Primary Sponsor
|
| Name |
SARDAR PATEL MEDICAL COLLEGE, BIKANER |
| Address |
DEPATMENT OF ANAESTHESIA,PBM HOSPITAL,BIKANER |
| 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 |
| SIMRITA |
SARDAR PATEL MEDICAL COLLEGE |
DEPTT. OF ANAESTHIOLOGY, PBM HOSPITAL, BIKANER
Bikaner
RAJASTHAN |
7009248350
simritagill21@gmail.con |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICAL RESEARCH BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMBINED SPINAL EPIDURAL WITH EPIDURAL VOLUME EXTENSION |
INTRATHECAL LOW DOSE ROPIVICAINE INJECTION IS GIVEN AND THEN 10 ML OF NS IS INJ INTO EPIDURAL SPACE AFTER 5 MINS |
| Comparator Agent |
COMBINED SPINAL EPIDURAL WITHOUT EPIDURAL VOLUME EXTENSION |
INTRATHECAL DRUG ADMINISTRATION IS DONE WITHOUT EVE |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2
HEIGHT 150 TO 170 CM
WEIGHT 40 TO 75
PATIENT UNDERGOING ELECTIVE LOWER LIMB SURGERIES |
|
| ExclusionCriteria |
| Details |
ASA 3 AND 4, PATIENT REFUSAL,PRE-EXISTING NEUROLOGICAL DISEASE, COAGULOPATHY, SURGEREIES MORE THAN 3 HRSINFECTION AT INJECTION SITE, |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
SENSORY- LEVEL ,ONSET ,DURATION
MOTOR-ONSET,DURATION
|
O MIN, 5 MINS 10 MINS 15 MINS, 30 MINS 45 MINS, 60 MINS 2HRS 4 HRS 6 HRS 8 HRS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HAEMODYNAMIC PARAMETERS,PATIENT SATISFACTION,SIDE EFFECTS |
FIRST 24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will conduct a study in 60 patients belonging ASA grade I and II aged between 45 to 65 years undergoing lower limb surgeries in Sardar Patel medical college, Bikaner(Rajasthan). This study will be aimed to identify the effectiveness of block profile provided by extending the epidural volume with normal saline for lower limb orthopaedic surgeries using a low dose intrathecal hyperbaric ropivacaine without causing hemodynamic changes. The majority of lower extremity orthopaedic surgery patients are old age and have multiple coexisting medical problems. Ensuring hemodynamic stability in these patients requires selection of appropriate techniques of regional anaesthesia, focussing on maintaining a safe and desirable level of blockade and limiting extensive sympathectomy.Combined spinal epidural anaesthesia will be given to both groups.Spinal anaesthesia will be given low dose isobaric 0.75% Ropivicaine. Group A will receive 10 ml of normal saline after 5 mins of intrathecal drug administration(EVE). Group B will not receive EVE A. PRIMARY AIM- • To assess and to compare the sensory blockade in terms of onset, level and regression. • To assess and to compare the motor blockade in terms of onset level and recovery. • To compare the time at which first rescue analgesia is given epidurally. B. SECONDARY AIM- • To observe the haemodynamic parameters.
• To observe patient and surgeon satifaction.
• To observe any side effects and complications related to drugs.
|