| CTRI Number |
CTRI/2025/03/082332 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of the ratio obtained by dividing the hip width by shoulder width of a person on the spread of the drug bupivacaine heavy injected in the fluid filled space around the spinal cord in patients undergoing surgeries below the level of umbilicus. |
|
Scientific Title of Study
|
Correlation between
hip/shoulder - width ratio and intrathecal spread of hyperbaric bupivacaine –A
Prospective Observational Study |
| 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 Ajay Kumar |
| Designation |
Senior Specialist & HOD |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi |
| Address |
Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
West
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divyansh Gaur |
| Designation |
Secondary DNB |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi |
| Address |
Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
West
DELHI
110064
India |
| Phone |
9435975530 |
| Fax |
|
| Email |
drdivyanshgaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Dwivedi |
| Designation |
Senior Medical Officer |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi |
| Address |
Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
West
DELHI
110064
India |
| Phone |
9999178199 |
| Fax |
|
| Email |
drpuneetdwivedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi, Hari Nagar, New Delhi
West
DELHI
110064
India |
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi, 110064 |
| 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 Ajay Kumar |
Deen Dayal Upadhyay Hospital, Govt of NCT of delhi |
MOT1,MOT2,Trauma OT,Dept of Anaesthesiology & Critical Care, Hari Nagar, New Delhi, 110064
West
DELHI |
9718990114
ajayannu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Deen Dayall Upadhyay Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients of ASA I/II category undergoing infraumbilical surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.History of allergy to bupivacaine.
2.Contraindication for spinal anaesthesia.
3.Spinal deformity.
4.Patients with h/o previous spine surgery.
5.Patients who are not able to sit straight.
6.Failure to perform lumbar puncture at L3-L4 intervertebral space in the midline.
7.Any change in patient position or table position within 30 minutes of spinal anaesthesia.
8.Patients with h/o previous hip/pelvic surgery.
9.Patients posted for hip/pelvic surgeries.
10.Patients with intra-abdominal tumors or mass.
11.Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyze the correlation between hip/shoulder - width ratio and maximum sensory
blockade to pin prick sensation. |
The cephalad spread of spinal anaesthesia will be assessed at 5-minute intervals till 30 minutes after intrathecal injection and the level of spread 30 minutes after intrathecal injection will be used for the analysis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the correlation of age, height, weight, vertebral column length with maximum
sensory blockade to pin prick sensation. |
The cephalad spread of spinal anaesthesia will be assessed at 5-minute intervals till 30 minutes after intrathecal injection and the level of spread 30 minutes after intrathecal injection will be used for the analysis. |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
26/03/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background: Various factors including anthropometric measurements are known to affect the cephalad spread of spinal anaesthesia. Out of these, certain anthropometric values can be easily measured and are helpful in predicting the level of sensory block after giving spinal anaesthesia.
Aim: The Aim of our study is to evaluate the correlation between hip/shoulder width ratio and intrathecal spread of hyperbaric bupivacaine.
Settings and Design: This Prospective observational study will be conducted at Deen Dayal Upadhyay Hospital, New Delhi after obtaining approval from the Scientific Research committee, Institutional Ethics Committee and written informed consent of participating patients.
Material and Methods: One hundred eleven patients fulfilling the inclusion criteria undergoing infraumbilical surgeries under spinal anaesthesia will be enrolled in the study. Preoperatively from the back side, hip-width of the patient will be measured between the two iliac crests, shoulder-width will be measured between the two acromion processes and vertebral column length will be measured between C7 vertebra and sacral hiatus with the patient in sitting position. Patient age, sex, height and weight will also be recorded. Using a 25G Quincke’s needle, 3 ml of 0.5 % hyperbaric bupivacaine will be administered intrathecally to the patient in a lateral decubitus position at L3-L4 interspace. The cephalad spread of spinal anaesthesia will be assessed using loss of pinprick sensation at 5 minute intervals till 30 minutes after intrathecal injection. The level of spread 30 minutes after intrathecal injection will be used for analysis.
Statistical Analysis: Spearman/Pearson correlation coefficient and multivariate linear regression model will be used for the analysis of correlation between study factors and level of sensory block.
Conclusion: This study will be helpful in evaluating the correlation between hip/shoulder – width ratio and spread of spinal anaesthesia in Indian population. |