| CTRI Number |
CTRI/2024/02/062220 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the effect of two drugs with adjuvant in spinal anesthesia on post operative pain duration in pregnant women undergoing elective caesarean section |
|
Scientific Title of Study
|
A randomized comparative study to assess the effect of intrathecal magnesium sulphate as an adjuvant to hyperbaric bupivacaine versus isobaric levobupivacaine on post operative analgesia in parturients undergoing elective caesarean section at SMS Medical college Jaipur |
| 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 Savita Meena |
| Designation |
Associate Professor |
| Affiliation |
Department of anaesthesia sawai man singh medical college and attached hospital |
| Address |
Department of anaesthesia sawai man singh medical college and attached hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290969216 |
| Fax |
|
| Email |
drsavita020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Meena |
| Designation |
Associate Professor |
| Affiliation |
Department of anaesthesia sawai man singh medical college and attached hospital jaipur |
| Address |
Department of anaesthesia sawai man singh medical college and attached hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290969216 |
| Fax |
|
| Email |
drsavita020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shravan kumar jat |
| Designation |
Resident doctor |
| Affiliation |
Department of anaesthesia sawai man singh medical college and attached hospital jaipur |
| Address |
Department of anaesthesia sawai man singh medical college and attached hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
9694846676 |
| Fax |
|
| Email |
sksaran45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia sawai man singh medical college and attached hospital jaipur |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia sawai man singh medical college and attached hospital jaipur |
| Address |
Department of anaesthesia sawai man singh medical college and attached hospital
Jaipur
Rajasthan
302004 |
| 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 Savita Meena |
Sawai man singh medical college and attached hospital jaipur |
Department of anaesthesia sawai man singh medical college and attached hospital
Jaipur
Rajasthan
302004
Jaipur
RAJASTHAN |
8290969216
drsavita020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O298||Other complications of anesthesiaduring pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric bupivacaine 10 mg with magnesium sulphate 75 mg and Isobaric levobupivacaine 10 mg with magnesium sulphate 75 mg |
To assess the effect of intrathecal magnesium sulphate 75 mg as an adjuvant to hyperbaric bupivacaine 10 mg versus isobaric levobupivacaine 10 mg on post operative analgesia in parturients undergoing elective caesarean section.
Frequency - single time.
Route of administration - Subarachenoid or Intrathecal.
Duration of intervention - Single injection. |
| Intervention |
Spinal anaesthesia in elective caesarean section |
To assess the effect of intrathecal magnesium sulphate 75 mg as an adjuvant to hyperbaric bupivacaine 10 mg versus isobaric levobupivacaine 10 mg on post operative analgesia in parturients undergoing elective caesarean section.
Frequency - single time.
Route of administration - Subarachenoid or Intrathecal.
Duration of intervention - Single injection. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Written Informed consent for this study
2. Adult age group
3. Patients undergoing elective caesarean section
4. Gestational age 37-42 weeks
5. ASA Grade-â…¡
|
|
| ExclusionCriteria |
| Details |
1. High risk pregnancy like intrauterine growth restriction, eclampsia, preeclampsia, short stature, twin Gestation, maternal cardiovascular disorders, Endocrine disorders, pulmonary disorders, Chronic kidney and liver disorders
2. Parturient with contraindications for neuraxial block like lack of consent, elevated ICP, preexisting neurological disease, severe dehydration, hypovolemia, thrombocytopenia, coagulopathy, history of allergy to study drug
3. Patient should not be a part of other study
4. Non co-operative patient
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean duration of Post op analgesia.
|
1. 0 hrs
2. 1 hrs
3. 3 hrs
4. 6 hrs
5. 12 hrs
6. 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean time of onset of sensory block (minutes).
2. Mean time of onset of motor block (minutes).
3. Mean time taken for sensory regression of two segments (minutes).
4. Mean time taken for complete motor recovery (minutes).
5. Mean duration of sensory block (minutes).
6. Mean duration of motor block (minutes).
7. Mean haemodynamic parameters. (HR, SBP, DBP, MAP).
8. Mean APGAR score.
|
1. 2 min.
2. 4 min.
3. 6 min.
4. 8 min.
5. 10 min.
6. 15 min.
7. 20 min.
8. 25 min.
9. 30 min.
10. 40 min.
11. 50 min.
12. 60 min. |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
05/02/2024 |
| 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="0"
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
|
Spinal
Anaesthesia with hyperbaric bupivacaine and isobaric levobupivacaine is the
most preferred technique of Anaesthesia in parturient undergoing lower segment
caesarean sections (LSCS) which provides effective pain relief during intra operative
and early postoperative period along with avoiding the risks of general
Anaesthesia. However, recent studies show us that about 50%–70% of patients
complain of moderate to severe pain after LSCS indicating that postoperative
pain remains poorly managed.
For
this a total of 74 patients (n=74) undergoing elective caesarean section who
satisfy the inclusion criteria will be randomly divided into two groups of 37
each (A and B). Group A patients will be receiving hyperbaric bupivacaine 0.5% plus magnesium sulphate (75 mg) and group B will be receiving isobaric levobupivacaine 0.5%
plus magnesium sulphate (75 mg).
When
patients arrive in the operating room (OR), intravenous cannula (IV cannula)
will be secured and hemodynamic variables will be measured. After this, spinal Anaesthesia
will be administered using hyperbaric
bupivacaine 0.5% plus magnesium sulphate
(75 mg) in group A and isobaric levobupivacaine 0.5% plus magnesium sulphate
(75 mg) in group B. Surgery will start after the block reaches T6 sensory level
(complete sensory block). Quantitative values of time of onset of sensory loss,
time of onset of complete motor block, time taken for sensory regression and
post operative analgesia will be recorded.
|