| CTRI Number |
CTRI/2024/07/071013 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing two different techniques to correctly identify space between lower backbone in pregnant females |
|
Scientific Title of Study
|
Sacral anatomical interspace landmark (SAIL) technique Vs classical intercristal line landmark (CILL) technique- a prospective diagnostic study for accurate identification of lumbar intervertebral space in parturients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikitha Jameel |
| Designation |
Junior Resident |
| Affiliation |
Post-Graduate institute of medical education and research |
| Address |
Department of Anaesthesia and Intensive Care, 4th floor Main OT complex, Nehru Hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08848078032 |
| Fax |
|
| Email |
nikithajameel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Anil Gandhi |
| Designation |
Associate Professor |
| Affiliation |
Post-Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, 4th floor Main OT complex, Nehru Hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087003376 |
| Fax |
|
| Email |
dr.komalgandhi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikitha Jameel |
| Designation |
Junior Resident |
| Affiliation |
Post-Graduate institute of medical education and research |
| Address |
Department of Anaesthesia and Intensive Care, 4th floor Main OT complex, Nehru Hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8848078032 |
| Fax |
|
| Email |
nikithajameel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Hospital, Post-Graduate Institute of Medical Education and Research, Sector 12,
Chandigarh 160012 |
|
|
Primary Sponsor
|
| Name |
Post-Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, 4th Floor, A block, Nehru hospital, Post-Graduate Institute of Medical Education and Research, Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nikitha Jameel |
Post-Graduate Institute of Medical Education and Research |
3rd floor, Labor room
operation theatre and
pre-operative area, Nehru
Hospital
Chandigarh
CHANDIGARH |
08848078032
nikithajameel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80-O82||Encounter for delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Classical intercristal line landmark (CILL) technique |
Palpate the posterior iliac crests of all the research participants with research participants in sitting position with neck, back and hips flexed. The investigator will slide her hands medially along an imaginary line connecting both the posterior iliac crests. This line typically crosses the midline at the L4 vertebra or the L4-L5 intervertebral region. An experienced anaesthesia provider will scan all the participants’ lumbosacral spine area with the study participant sitting in the same flexed position. Investigator will check actual level of clinical estimate measurements for L4-L5 intervertebral level markings done using CILL technique. |
| Intervention |
Sacral Anatomical Interspace Landmark (SAIL) Technique |
With all the research participants in sitting position with their neck, back, and hips flexed, palpate the lower part of dorsal surface of the sacrum, the investigator would slide her hand in a cephalad direction to identify the first intervertebral space between the sacrum and the last lumbar vertebra (L5-S1). Then slide the hand up for one more intervertebral space to identify the L4-L5 intervertebral space. An experienced anaesthesia provider will scan all the participants’ lumbosacral spine area with the study participant sitting in the same flexed position. Investigator will check actual level of clinical estimate measurements for L4-L5 intervertebral level markings done using SAIL technique. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Parturients with age more than 18 years,
Singleton pregnancy,
Gestational age more than 37 weeks |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate,
2.Non- cooperative with the required positioning,
3.History of previous spine surgery,
4.Known case of spine deformities,
5.Second and third stage of labor,
6.Morbid obesity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the accuracy in identifying L4-L5 intervertebral space with SAIL technique Vs CILL technique in parturients. |
Preoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the occurrence of estimated measurements falling above L3 vertebra with SAIL technique Vs CILL technique in parturients. |
Preoperative |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
01/08/2024 |
| 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="10"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective diagnostic study comparing the accuracy of Sacral Anatomical Interspace Landmark (SAIL) technique Vs Classical Intercristal Line Landmark (CILL) technique to identify L4-L5 intervertebral space in parturients. Preoperative evaluation of parturients will be conducted for checking eligibility as per inclusion criteria. After the written informed consent, eligible parturients will be enrolled as study participants. Participants’ demographic details, medical history and relevant general physical examination will be noted. In the labour room or ward area, participants will be asked to sit to one side of a levelled streture / patient trolley with her neck, back and hips flexed. The independent anaesthesia provider well versed with the study techniques will mark all participants’ back at the estimated L4-L5 intervertebral space using the two study techniques-The Sacral Anatomical Interspace Landmark (SAIL) Technique and The classical intercristal line landmark (CILL) technique. The sequence of techniques will be randomized using the computer-generated random number table. A lumbo-sacral spine ultrasonography experienced anaesthesia provider will scan the participants’ lumbosacral spine area with the study participant sitting in the same flexed position. He/she will check actual level of clinical estimate measurements for L4-L5 intervertebral level markings done using the CILL as well as SAIL techniques.
|