| CTRI Number |
CTRI/2025/03/082203 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Analytical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know back pain after spinal anaesthesia with alternate method (Taylor method) in place of standard method |
|
Scientific Title of Study
|
Evaluation of Post Spinal Back Pain with Taylor versus Median Approach for Spinal Anaesthesia |
| 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 Pawan Dewda |
| Designation |
Junior Resident, Gandhi Medical College |
| Affiliation |
Gandhi Medical College |
| Address |
Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal M.P.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9589615681 |
| Fax |
|
| Email |
pawandewda06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweyta Shrivastava |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College |
| Address |
Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal M.P.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425543210 |
| Fax |
|
| Email |
sweyta2907@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sweyta Shrivastava |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College |
| Address |
Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal M.P.
MADHYA PRADESH
462001
India |
| Phone |
9425543210 |
| Fax |
|
| Email |
sweyta2907@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal MADHYA PRADESH India 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College Bhopal Madhya Pradesh |
| Address |
Sultania Road Royal Market Bhopal Madhya Pradesh India 462001 |
| 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 |
| Dr Sweyta Shrivastava |
Hamidia Hospital |
Block A Second Floor Operation Theatre Gandhi Medical College Bhopal M.P.
Bhopal
MADHYA PRADESH |
9425543210
sweyta2907@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMC Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Median Approach |
Infiltration of the puncture site with 2% lignocaine is done.
subarachnoid block will be given at the L3–4 or L4–5 intervertebral space.
the needle is inserted
below the Low edge of the spinous process of the selected upper
vertebrae and passes through the supraspinous ligament, interspinous
ligament, ligamentum flavum, and epidural space, piercing the dura
mater, free flow of CSF is obtained confirming successful location of proper needle placement and 0.5% hyperbaric bupivacaine (Bupivacaine Heavy Injection 0.5%) is injected
|
| Intervention |
Taylors Approach |
Infiltration of the puncture site with 2% lignocaine is done.
It is carried out at L5 -S1 interspace, the largest interlaminar space of
the vertebral column. Spinal needle is inserted in a cephalomedial direction through a skin wheal raised 1 cm medial and 1 cm caudal to
the lower most prominence of the posterior superior iliac spine. The
needle is walked off the sacrum to enter the Subarachnoid space,
free flow of CSF is obtained confirming successful location of proper needle placement and 0.5%
hyperbaric bupivacaine (Bupivacaine Heavy Injection 0.5%) is injected |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients scheduled for below umbilical elective surgeries under Sub Arachnoid Block
Patient of ASA physical status I and II
|
|
| ExclusionCriteria |
| Details |
Patient complaining of Pre existing chronic back pain
Bleeding diathesis and patients on anticoagulants and antiplatelet drugs
Hypersensitivity to local anaesthetics |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of patients affected by post spinal back pain |
Severity of low back pain at Day1 and Day 7 via NRS and Prestructured validated questionnaire and at 3 months via post telephonic conversations |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine the onset duration severity of post spinal back pain |
Severity of low back pain at Day1, Day 7 via NRS and Prestructured validated questionnaire and at 3 months via post telephonic conversations |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
10/04/2025 |
| 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="1"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 03-05-2024 and end date provided 03-05-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Then patient will be taken for Spinal Anaesthesia with Standard Institutional anaesthesia protocol. In both approaches ,subarachnoid block will be performed with 0.5% hyperbaric Bupivacaine Heavy , using a 23-gauge spinal needle, by anaesthesiologist. In Median Approach : subarachnoid block will be given at the L3–4 or L4–5 intervertebral space. In Taylor’s Approach subarachnoid block at L5-S1 intervertebral space. The dose of Bupivacaine injected intrathecally depended on the duration of surgical procedure. Rescue analgesia for 24 hours post operative pain control. |