| CTRI Number |
CTRI/2021/01/030779 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
26/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prospective observational study of incidence and factors associated with failed spinal anesthesia in obstetric patients. |
|
Scientific Title of Study
|
PROSPECTIVE OBSERVATIONAL STUDY OF INCIDENCE AND FACTORS ASSOCIATED WITH FAILED SPINAL ANESTHESIA IN OBSTETRIC PATIENTS. |
| Trial Acronym |
IFSA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JHARNA MILI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KGMU |
| Address |
DEPARTMENT OF ANAESTHESIA
KGMC DEPARTMENT OF ANAESTHESIA Lucknow UTTAR PRADESH 226003 India |
| Phone |
9101450238 |
| Fax |
|
| Email |
jharnamili25@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Professor Monica Kohli |
| Designation |
Professor |
| Affiliation |
king george medical university |
| Address |
Department of Anaesthesiology
First floor
King George Medical University Department of Anaesthesiology
First floor
King George Medical University Lucknow UTTAR PRADESH 226003 India |
| Phone |
9839041228 |
| Fax |
|
| Email |
monica_kohli@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
JHARNA MILI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KGMU |
| Address |
DEPARTMENT OF ANAESTHESIA DEPARTMENT OF ANAESTHESIA
KGMC Lucknow UTTAR PRADESH 226003 India |
| Phone |
9101450238 |
| Fax |
|
| Email |
jharnamili25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KGMU |
| Address |
KGMU |
| 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 |
| JHARNA MILI |
KING GEORGE MEDICAL UNIVERSITY |
QUEEN MARY HOSPITAL,
KING GEORGE MEDICAL UNIVERSITY
SHAHMINA ROAD, CHOWK Lucknow UTTAR PRADESH |
9101450238
jharnamili25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGE MEDICAL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, (2) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.PATIENT AGED MORE THAN 18YEARS UNDERGOING BOTH ELECTIVE AND EMERGENCY CAESAREAN SECTION IN KING GEORGE MEDICAL UNIVERSITY DURING STUDY PERIOD .
2. AMERICAN SOCIETY OF ANAESTHESIOLOGIST PHYSICAL STATUS CLASSIFICATION I-III. |
|
| ExclusionCriteria |
| Details |
1.PATIENT NOT GIVING CONSENT
2. PATIENTS WITH CONTRAINDICATIONS TO SPINAL ANAESTHESIA
3. PATIENTS WHO ARE UNDERGOING COMBINED SPINAL EPIDURAL ANAESTHESIA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of unsuccessful spinal anesthesia (total or partial ) in obstetric patients. |
1.5 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the factors associated with failed spinal anesthesia
2. To determine the first attempt success (identification of subarachnoid space at first spinal puncture).
3. To determine the incidence of conversion to general anesthesia . |
1.5YEARS |
|
|
Target Sample Size
|
Total Sample Size="640" Sample Size from India="640"
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)
|
31/01/2021 |
| 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="1" Months="2" Days="2" |
|
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
|
Spinal anaesthesia is commonly use to provide regional anaesthesia for elective and emergency caesarean section. apart from excellent anaesthesia , it also avoids the complication of general anaesthesia. It provides rapid onset of anaestheisia, good surgical conditions , a reliable and predictable block and excellent post-operative analgesia. Failed spinal anaesthesia is defined as a partial or incomplete spinal block requiring supplemental analgesia or conversion to general anaesthesia. The incidence of failed spinal anaesthesia varies from centre to centre and time to time within the same centre. A retrospective analysis of almost 5000 spinal anaesthesia by Horlocker and colleagues reported 1% failure rate. Parikh KH et al have found that with careful performance of technique , failure rate of as low as 1% is attainable. Sprung Juraj et al concluded that most reliable method of determining the potential for technically difficult block is the examination of patients for quality of landmarks and other obvious factors. the suggestion from these report is that with meticulous attention to detail and appropriate management , most failure of spinal anaesthesia could be prevented . This observational study will be conducted to investigate the incidence of failure of spinal anaesthesia , first attempt success, conversion to general anaesthesia and factors associated with failed spinal anaesthesia in obstetric patients requiring caesarean section in King Georges Medical University ., Lucknow. |