| CTRI Number |
CTRI/2023/05/052352 [Registered on: 08/05/2023] Trial Registered Prospectively |
| Last Modified On: |
04/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
postdural puncture headache and low backache in median and paramedian approach in caesarean section. |
|
Scientific Title of Study
|
Incidence of postdural puncture headache and low backache following median versus paramedian approach under spinal anaesthesia in elective caesarean section: A randomized double blind trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHREYA DUTTA |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,3RD FLOOR,KIMS,KIIT UNIVERSITY,BHUBANESWAR,ORISSA-751024
Khordha
ORISSA
751024
India |
| Phone |
6901963606 |
| Fax |
|
| Email |
2287017@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARTHA SARATHI MOHAPATRA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
FLAT NO-106,A BLOCK,JAGANNATH PLAZA,GAJAPATI NAGAR,BHUBANESWAR,ORISSA,PIN-751005
Khordha
ORISSA
751005
India |
| Phone |
7008832969 |
| Fax |
|
| Email |
partha.mohapatra@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PARTHA SARATHI MOHAPATRA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
FLAT NO-106,A BLOCK,JAGANNATH PLAZA,GAJAPATI NAGAR,BHUBANESWAR,ORISSA,PIN-751005
Khordha
ORISSA
751005
India |
| Phone |
7008832969 |
| Fax |
|
| Email |
partha.mohapatra@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| department of anesthesia
KALINGA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
DR. SHREYA DUTTA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,3RD FLOOR,KIMS,KIIT UNIVERSITY,BHUBANESWAR,ORISSA |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 PARTHA SARATHI MOHAPATRA |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
3RD FLOOR, DEPARTMENT OF ANAESTHESIA, KIMS, KIIT UNIVERSITY, BHUBANESWAR, ORISSA 751024
Khordha
ORISSA |
7008832969
Partha.mohapatra@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SUBARACHANOID BLOCK IN MEDIAN APPROACH |
Group M-Subarachnoid block is given through median approach using Quinckes 25G needle with Bupivacaine 2.2ml,Butorphanol 0.2mg.
Duration- 24hr,72 hr, 7 days for pdph
Duration-7 days ,1 months,3months for post spinal backache. |
| Intervention |
SUBARACHNOID BLOCK IN PARAMEDIAN APPROACH |
Group P- Subarachnoid block is given through through paramedian approach using Quinckes 25G with Bupivacaine 2.2ml,Butorphanol 0.2mg.
Duration- 24hr,72 hr, 7 days for pdph
Duration-7 days ,1 months,3months for post spinal backache. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients posted for elective caesarean section under spinal anaesthesia
2.American Society of Anaesthesiologists (ASA) physical status-II III
3.Age 18-40 years
|
|
| ExclusionCriteria |
| Details |
1.Any contraindication to spinal anaesthesia.
2. Any chronic preoperative headache, cluster headache, stress headache
3. Patient with chronic backache.
4.History of Pelvic inflammatory disease.
5.Lumbar puncture attempt greater than three
6.BMI>35
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of PDPH in two different approaches of subarachnoid block |
24hr,72 hr 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The severity of headache at 24hrs,72hrs and after a week using VAS score
2.The post spinal backache at 7 days,1 month,3 months using VAS score.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Paramedian approach can be considered as a superior alternative to median approach under spinal anaesthesia in reducing post dural puncture headache and low backache in routine practice by overcoming the disadvantaged of paramedian approach thereby decreasing the postoperative ambulation time. |