| CTRI Number |
CTRI/2021/01/030255 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
04/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on spinal anaesthesia failures in caesarean operation |
|
Scientific Title of Study
|
A prospective observational analysis of spinal anaesthesia failures in caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
suvarna kaniyil |
| Designation |
additional professor |
| Affiliation |
government medical college- Kozhikode, Kerala, India |
| Address |
Department of anaesthesia,
Government medical college-Kozhikode, Kerala, India
Kannur KERALA 673008 India |
| Phone |
9447638221 |
| Fax |
|
| Email |
suvarnakaniyil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
suvarna kaniyil |
| Designation |
additional professor |
| Affiliation |
government medical college- Kozhikode, Kerala, India |
| Address |
Department of anaesthesia,
Government medical college-Kozhikode, Kerala, India
Kannur KERALA 673008 India |
| Phone |
9447638221 |
| Fax |
|
| Email |
suvarnakaniyil@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
suvarna kaniyil |
| Designation |
additional professor |
| Affiliation |
government medical college- Kozhikode, Kerala, India |
| Address |
Department of anaesthesia,
Government medical college-Kozhikode, Kerala, India
Kannur KERALA 673008 India |
| Phone |
9447638221 |
| Fax |
|
| Email |
suvarnakaniyil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia,
Government medical college-Kozhikode, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Dr Suvarna Kaniyil |
| Address |
Department of anaesthesia,
government medical college-Kozhikode, Kerala, India |
| Type of Sponsor |
Other [Primary investigator. No funding required as this is only an observational study] |
|
|
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 SuvarnaK |
Operation theatre,IMCH |
IMCH, Government medical college-Kozhikode Kozhikode KERALA |
9447638221
suvarnakaniyil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Government medical college Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant patients coming for emergency and elective caesarean sections during the study period |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Failure rate in regional anesthesia among patients undergoing caesarean sections. |
From 20 minutes after giving regional anesthesia to completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Managent of failed regional anaesthesia cases.
2.Factors associated with failure |
Intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
11/01/2021 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objectives: Objectives of this study are to observe the anaesthetic practices for CS to find out the regional anaesthesia failure rate and subsequent management of it. All possible risk factors contributed to failure will also be looked for. Materials and methods: This prospective observational study will be conducted at Govt medical college, Kozhikode from January 2021 to Jun 2021.Observetios and data collection will be done by the junior resident posted in obstetric OT. Anaesthetic practice in all emergency and elective CS in which spinal anaesthesia was given will be observed to find out the failure rate of spinal anaesthesia and subsequent management of such cases. All cases in which satisfactory analgesia (T6 dermatomal sensory analgesia) is not attained in 20 minutes of lumbar puncture, patient complained of any discomfort or pain during surgery or the duration of spinal anaesthesia was inadequate (< 2hrs) are considered as failed spinal anaesthesia. The subsequent management of these failed spinal anaesthesia cases will be observed. The data will be collected by a junior resident posted in obstetric OT and the consultant anaesthesia provider of that theatre will be unaware of the study. The demographic details of parturients, indications and duration of CS, technical details of RA, the rate of GA conversion, repeat spinal, supplemental analgesia/ sedation and any complications will be noted. Any contributing factors for failure will be looked for. |