| CTRI Number |
CTRI/2021/05/033687 [Registered on: 20/05/2021] Trial Registered Prospectively |
| Last Modified On: |
08/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different positions to administer spinal anaesthesia in pregnant women for planned cesarean section. |
|
Scientific Title of Study
|
Comparison of spinal anaesthesia in traditional sitting position versus cross legged sitting position in parturients undergoing elective cesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Intekhab Ahmad Khan |
| Designation |
Junior resident, Anaesthesiology |
| Affiliation |
KMC Manipal MAHE |
| Address |
Department of Anaesthesiology,
1st floor CSOT building, KMC manipal,MAHE ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
int1koool9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi Shenoy |
| Designation |
Associate Professor,Anaesthesiology |
| Affiliation |
KMC Manipal MAHE |
| Address |
Department of Anaesthesiology,
1st floor CSOT building, KMC manipal,MAHE ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
laxmi.anaesthesia@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Shenoy |
| Designation |
Associate Professor,Anaesthesiology |
| Affiliation |
KMC Manipal MAHE |
| Address |
Department of Anaesthesiology,
1st floor CSOT building, KMC manipal,MAHE ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
laxmi.anaesthesia@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, MAHE Manpial Udupi Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Intekhab Ahmad Khan |
| Address |
Department of Anaesthesiology,
1st floor CSOT building, KMC manipal,MAHE ,Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 Intekhab Ahmad Khan |
Kasturba Hospital Manipal |
Department of Anesthesiology Kasturba Hospital Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
Women and Child block Major OT WNC OT 1, WNC OT 2
Udupi
KARNATAKA |
7020113913
int1koool9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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
|
| Type |
Name |
Details |
| Intervention |
Administering spinal anaesthesia in cross legged sitting position |
Administering spinal anaesthesia in women undergoing elective cesarean section in cross legged sitting position. |
| Comparator Agent |
Administering spinal anaesthesia in traditional sitting position |
Administering spinal anaesthesia in women undergoing elective cesarean section in traditional sitting position. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade 2 parturients undergoing elective cesarean section with age 18 to 50 years
BMI <35 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA 3 and ASA 4 patients
Obvious scoliosis/spinal deformity
Surgical scar in lumbar area
Skin infection in the lumbar area
Coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare single attempt successful needle placement in traditional sitting position versus cross legged sitting position. |
Number of attempts in the given position at the time of procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Block characteristics and hemodynamic changes
|
From the time of administration of drug-2mins ,5mins then every 5mins till 30 mins. |
| Ease of landmark palpation and needle-bone contact |
During and immediately after the procedure-ease of palpation
Number of needle bone contacts. |
| Patient comfort |
After the procedure on a likert scale. |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
17/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 a preferred anaesthesia for an elective cesarean section as it has numerous advantages for both baby and mother. Anatomical changes during pregnancy make spinal anaesthesia technically challenging for an anesthesiologist. Patient positioning is very important as it improves the patient comfort, reduces the time taken and the number of attempts required, and also decreases the number of needle to bone contact during the procedure. In this study, we are comparing the above mentioned points in two positions namely traditional sitting position and cross legged sitting position in women undergoing elective cesarean section. The study is based on the hypothesis that cross legged sitting position provides optimal lumbar flexion of the spine providing better access to the intervertebral spaces and better patient comfort, as seen in one of the previous studies measuring posterior longitudinal ligament, ligamentum flavum and interlaminar distances, ultrasonographically, in pregnant women for epidural placement.
|