| CTRI Number |
CTRI/2022/10/046762 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
23/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY COMPARING THE INCIDENCE OF HEADACHE AFTER SPINAL ANESTHESIA USING WHITACRE NEEDLE WITH MEDIAN AND PARAMEDIAN APPROACH IN CESAREAN SECTION PATIENTS |
|
Scientific Title of Study
|
A RANDOMIZED SINGLE BLINDED STUDY COMPARING THE INCIDENCE OF POST DURAL PUNCTURE HEADACHE AFTER SPINAL ANESTHESIA USING 25 GAUGE WHITACRE NEEDLE WITH MEDIAN AND PARAMEDIAN APPROACH IN CESAREAN SECTION PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BALEEGARA MAHAMMAD SALMAN |
| Designation |
POSTGRADUATE |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES , |
| Address |
DR. BALEEGARA MAHAMMAD SALMAN, POSTGRADUATE, DEPT. OF ANESTHESIOLOGY, KARNATAKA INSTITUTE OF MEDICAL SCIENCES , VIDYANAGAR, HUBLI
Dharwad
KARNATAKA
580022
India |
| Phone |
7619161036 |
| Fax |
|
| Email |
dr.mahammad.salman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAGHAVENDRA BHOSALE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES , |
| Address |
DR. RAGHAVENDRA BHOSALE, ASSOCIATE PROFESSOR,
DEPT. OF ANESTHESIOLOGY, KARNATAKA INSTITUTE OF MEDICAL SCIENCES , VIDYANAGAR, HUBLI
Dharwad
KARNATAKA
580022
India |
| Phone |
9342943765 |
| Fax |
|
| Email |
raghavbhosale3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAGHAVENDRA BHOSALE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES , |
| Address |
DR. RAGHAVENDRA BHOSALE, ASSOCIATE PROFESSOR,
DEPT. OF ANESTHESIOLOGY, KARNATAKA INSTITUTE OF MEDICAL SCIENCES , VIDYANAGAR, HUBLI
Dharwad
KARNATAKA
580022
India |
| Phone |
9342943765 |
| Fax |
|
| Email |
raghavbhosale3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences,vidyanagar,Hubli |
|
|
Primary Sponsor
|
| Name |
DR BALEEGARA MAHAMMAD SALMAN |
| Address |
POSTGRADUATE DEPT OF ANESTHESIOLOGY KARNATAKA INSTITUTE OF MEDICAL SCIENCES HUBLI |
| Type of Sponsor |
Other [SELF] |
|
|
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 BALEEGARA MAHAMMAD SALMAN |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANESTHESIOLOGY, ROOM NUMBER 206, VIDYANAGAR, KIMS HUBLI, DHARWAD, KARNATAKA
Dharwad
KARNATAKA |
7619161036
dr.mahammad.salman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KIMS HUBLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
spinal anesthesia through median approach |
This group of caesarian section patients will receive 9-12mg of hyperbaric bupivacaine with 25G whitacre spinal needle through median approach |
| Intervention |
spinal anesthesia through paramedian approach |
This group of caesarian section patients will receive 9-12mg of hyperbaric bupivacaine with 25G whitacre spinal needle through paramedian approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American society of anesthesiologist grade 1,2
age 18-35years,
cesarean section under spinal anesthesia,
pregnant patients giving informed, written and valid consent,
at least 36weeks of gestational age,
singleton pregnancy,
|
|
| ExclusionCriteria |
| Details |
pregnant women with history of cardiac, liver and kidney disease,
American society of anesthesiologist grade 3,4,5
anatomical abnormalities of spine,
patient refusal,
pregnant women with allergy to amide local anesthetic,
more than 2 dural punctures,
history of migraine or any chronic headache preoperatively or on day of surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By this study we will come to know best approach to reduce the incidence of post dural puncture headache. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subarachnoid block is most commonly used anesthesia technique for cesarean section. PDPH is iotrogenic complication of spinal anesthesia. subarachnoid space can be approached from posterior aspect of vertebral body by either through median or paramedian approach. paramedian approach has been proven to decrease the incidence of PDPH. Whitacre needle has been proven to decrease the incidence of PDPH, Hence we decided to see the advantage of whitacre needle when used in paramedian approach compared to median approach. we planned to evaluate by combining the advantage of whitacre needle with advantages of paramedian approach to decrease the incidence of PDPH. |