| CTRI Number |
CTRI/2025/01/079259 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Does Spinal Anaesthesia cause long term Low Back Pain after Childbirth |
|
Scientific Title of Study
|
To assess the association of Spinal Anaesthesia with Chronic Low Back Pain Following Childbirth: 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 |
Runjhun Aggarwal |
| Designation |
Resident, MD Anaesthesia |
| Affiliation |
Hamdard Institute of Medical Sciences and Research, New Delhi |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B-Block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
8800194344 |
| Fax |
|
| Email |
runjhaggarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Panjiar |
| Designation |
Professor, Department of Anaesthesia |
| Affiliation |
Hamdard Institute of Medical Sciences and Research, New Delhi |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B-Block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
9311657822 |
| Fax |
|
| Email |
pratibha.panjiar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Runjhun Aggarwal |
| Designation |
Resident, MD Anaesthesia |
| Affiliation |
Hamdard Institute of Medical Sciences and Research, New Delhi |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B-Block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
8800194344 |
| Fax |
|
| Email |
runjhaggarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hamdard Institute of Medical Sciences and Research |
| Address |
Hamdard Institute of Medical Sciences and Research and HAHC Hospital, Hamdard Nagar, New Delhi, 110062 |
| Type of Sponsor |
Private 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 Runjhun Aggarwal |
HIMSR and HAHC Hospital |
8TH AND 2ND FLOOR OT COMPLEX, A Block and B Block, Old and New Hospital Building, Hamdard Institute of Medical Sciences and Research and Hakeem Abdul Hameed Centenary Hospital, Hamdard Nagar 110062
South
DELHI |
8800194344
runjhaggarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Hamdard Institute of Medical Sciences and Research and Associated HAHC Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.All women who deliver at HAHC Hospital either vaginally without anaesthesia, or cesarean delivery under spinal anaesthesia
2.The patient must be registered in Ante Natal Clinic at HAHC Hospital |
|
| ExclusionCriteria |
| Details |
1.Patients with preexisting low back pain before pregnancy, diagnosed lumbar spinal pathologies and diagnosed psychiatric disorders including depression and anxiety
2.Refusal to participate in study
3.Patients developing any complication after childbirth, requiring wound resuturing or have a complication for which they have to undergo any surgery within 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of chronic low back pain following childbirth in patients receiving spinal anaesthesia for Caesarean delivery versus in patients undergoing vaginal delivery without any anaesthesia technique |
D0 - day of delivery
D1 - 1st follow up in person
D7 - 2nd follow up telephonically
D90 - 3rd follow up telephonically |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the severity of chronic low back pain following childbirth in the two study groups
2.To determine the incidence of chronic low back pain following childbirth in the cohort oof patients presenting in our hospital
3.To study the association of physical factors during pregnancy and childbirth, with chronic low back pain following childbirth |
D0 - day of delivery
D1 - 1st follow up in person
D7 - 2nd follow up telephonically
D90 - 3rd follow up telephonically |
|
|
Target Sample Size
|
Total Sample Size="528"
Sample Size from India="528"
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)
|
05/02/2025 |
| 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="3"
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
|
This is an observational, prospective study to assess the association of spinal anaesthesia with chronic low back pain following childbirth The objectives of this study are - 1.To compare the incidence of chronic low back pain following childbirth in patients receiving spinal anaesthesia for caesarean delivery versus in patients undergoing vaginal delivery without any anaesthesia technique 2.To compare the severity of chronic low back pain following childbirth in the two study groups 3.To determine the incidence of chronic low back pain following childbirth in the cohort of patients presenting in our hospital 4.To study the association of physical factor during pregnancy and childbirth, with chronic low back pain following childbirth The trial will be conducted in the department of anaesthesiology and department of obstetrics and gynaecology of Hamdard Institute of Medical Sciences and Research |