| CTRI Number |
CTRI/2024/07/069822 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between single shot spinal anaesthesia and continuous spinal anaesthesia in cesarean section.
|
|
Scientific Title of Study
|
Efficacy of continuous spinal anaesthesia versus
single shot spinal anaesthesia in elective lower segment
cesarean section in terms of incidence and severity of hypotension |
| 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 Rupal Gupta |
| Designation |
pg resident |
| Affiliation |
Pt J N M medical college raipur cg |
| Address |
Department of anaesthesiology and pain medicine
Pt J N M Medical college raipur cg
Raipur
CHHATTISGARH
492001
India |
| Phone |
9753077756 |
| Fax |
|
| Email |
shreyag197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
Professor and HOD |
| Affiliation |
Pt J N M medical college raipur cg |
| Address |
Department of anaesthesiology and pain medicine
Pt J N M Medical college raipur cg
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupal Gupta |
| Designation |
pg resident |
| Affiliation |
Pt J N M medical college raipur cg |
| Address |
Department of anaesthesiology and pain medicine
Pt J N M Medical college raipur cg
Raipur
CHHATTISGARH
492001
India |
| Phone |
9753077756 |
| Fax |
|
| Email |
shreyag197@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and pain medicine
Pt J N M medical college , Raipur , CHHATTISHGARH
Pin-492001 , INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Rupal Gupta |
| Address |
Department of anaesthesiology and pain medicine
Pt J N M Medical college raipur cg |
| 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 Rupal Gupta |
Dr Bhimrao Ambedkar Memorial Hospital Raipur cg |
Room no-349,2nd floor Department of anaesthesiology and pain medicine , Raipur ,
India , PIN- 492001
Raipur
CHHATTISHGARH
Raipur
CHHATTISGARH |
9753077756
shreyag197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt J N M Medical College Raipur C G |
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 |
| Intervention |
Continous spinal anaesthesia |
Subarachnoid space will be accessed through 18 G Tuohys epidural needle at L4-L5 interspace after getting free flow of CSF 20 G epidural catheter will be inserted and advanced 2cm into subarachnoid space
Then needle will be removed carefully and catheter will be fixed and thereafter patient will be allow to lie supine
After confirmation of aspiration of CSF through the catheter
1 ml(5mg) of 0.5 percent bupivacaine (heavy) will be injected and flush with 0.5 ml normal saline (dead space of the catheter)
After 10 min if the sensory block level will not reach up to T4 level then 2nd aliquot of 0.3 ml 0.5 percent bupivacaine will be injected & flushed with 0.5 ml NS
Subsequently same repeated doses of Bupivacaine will be administered at 10min to achieve block up to T4 level If block upto T4 level will not achieve after 3 doses then it will be considered as failure
At the end of surgery fentanyl 25mcg will be injected through catheter and then the catheter will be removed
effect will be seen till 12hrs |
| Comparator Agent |
Single shot spinal anaesthesia |
subarachnoid space will be accessed through 25 G Quinkes
spinal needle at L4-L5 interspace After confirmation of aspiration
of CSF through the catheter single dose of2 ml (10mg) 0.5% Bupivacaine heavy
will be injected into the subarachnoid space
effect will be seen till 12hrs |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade II - III
Age: 20-45/ female
Height:140-170 cm
Weight: 40-60 kg
Patient undergoing elective LSCS |
|
| ExclusionCriteria |
| Details |
Refusing to be enrolled.
Any contraindication to spinal anaesthesia
Central nervous system disorder.
Bleeding and coagulation disorder.
Cardio respiratory disorder.
Any spinal deformity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of hypotension
Severity of hypotension |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total dose & number of boluses of mephenteramine required to manage hypotension
Time required to achieve block height up to T4
Duration of anaesthesia (injection of drug to 2 segment regression)
Duration of analgesia
Incidence of repeat spinal / repeat dose / supplement of SA / Conversion of GA
Incidence of adverse effects incidence & grades of shivering Post Op Nausea Vomiting (PONV) Post Dural Puncture Headache (PDPH) Neural Damage meningitis |
3 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
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
|
The thesis title Efficacy of continuous spinal anaesthesia versus single shot spinal anaesthesia for elective lower segment cesarean section in terms of incidence and severity of hypotension. A interventional study will be conducted in the department of anaesthesiology and pain medicine, Pt. J.N.M. Medical College and DR. B.R.A.M. Hospital Raipur (C.G.) after approval from institutional scientific and ethics committee.
A total of 100 (50 patients in each group) patients under age group of 20-45 years female of ASA grade II and III and undergoing elective lower segment cesearian section with a height of 140-170cm and weight of 40-60kg will be included in this study. All the enrolled parturients will be randomly placed into two groups to receive either continuous spinal anaesthesia (Group A) or single shot spinal anaesthesia (Group B) with the help of sealed envelope.
In CSA Group Group A, subarachnoid space will be accessed through 18 Gauge Tuoh’s epidural needle at L4-L5 interspace after getting free flow of cerebrospinal fluid, 20 gauge epidural catheter will be inserted and advanced 2cm into the subarachnoid space. Epidural needle will be removed carefully and epidural catheter will be fixed and thereafter patient will be allowed to lie supine. After confirmation of cerebrospinal fluid through the catheter, 1 ml of 0.5% bupivacaine heavy will be injected into the subarachnoid space and flush with 0.5 ml normal saline. After 10 minutes if the sensory block level will not reach upto T4 dermatome level then 2^nd aliquot of 0.3ml of 0.5% bupivacaine heavy will be injected and flushed with 0.5 ml normal saline. If block level not reach upto T4 dermatome level in 3 doses then it will be considered as failure. At the end of surgery fentanyl 25mcg will be injected with a flush of 0.5ml normal saline. After completion of surgery epidural catheter will be removed.
In SSSA Group Group B subarachnoid space will be accessed through 25 gauge Quinke’s spinal needle at L4-L5 interspace. After confirmation of aspiration of cerebrospinal fluid through the needle in the syringe a 2ml of single shot 0.5% bupivacaine heavy will be injected into the subarachnoid space and needle will be removed and patient allowed to lie in supine position and check the desired T5- T6 dermatome level to proceed the surgery.
After the injection in both the groups Heart Rate, Systolic Blood Pressure, Dystolic Blood Pressure, Mean Artrial Pressure, Severity and Incidence of Hypotension to be monitered every 3 minute upto 15 minute, and every 5 minute till completion of surgery. |