| CTRI Number |
CTRI/2025/07/091293 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effects of Spinal Anesthesia With Only Bupivacaine and With Bupivacaine Plus Morphine in Women Having a C-Section |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF SUCCEDENT VERSUS CONTROL INTRATHECAL ADMINSTRATION OF 0.5% HEAVY BUPIVACAINE WITH OR WITHOUT MORPHINE IN SPINAL BLOCK FOR CAESAREAN SECTION |
| 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 Jahanara |
| Designation |
Assistant professor |
| Affiliation |
GMC haldwani |
| Address |
CAMPUS block K 2 government medical college haldwani nainital
Department of Anaesthesiology critical care pain and palliative medicine 2nd floor Susheela Tiwari Government Hospital Haldwani Uttarakhand 263139
Nainital
UTTARANCHAL
263139
India |
| Phone |
8868057120 |
| Fax |
|
| Email |
dr.jahanara.malik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AK SINHA |
| Designation |
HOD of anaesthesia dept |
| Affiliation |
Government medical college, haldwani |
| Address |
Department of Anaesthesiology,critical care pain and palliative medicine 2nd floor Susheela Tiwari Government Hospital,Haldwani,Uttarakhand,263139
Department of Anaesthesiology critical care pain and palliative medicine 2nd floor Susheela Tiwari Government Hospital Haldwani,Uttarakhand,263139
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
sinhaak1961@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AK SINHA |
| Designation |
HOD of anaesthesia dept |
| Affiliation |
Government medical college, haldwani |
| Address |
Department of Anaesthesiology,critical care pain and palliative medicine 2nd floor Susheela Tiwari Government Hospital,Haldwani,Uttarakhand,263139
Department of Anaesthesiology critical care pain and palliative medicine 2nd floor Susheela Tiwari Government Hospital Haldwani,Uttarakhand,263139
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
sinhaak1961@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
dr jahanara |
| Address |
campus block 2 goverment medical college haldwani |
| Type of Sponsor |
Other [ (self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| dr rahul sexana |
behind shivkalan complex canal road haldwani kathgodam |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jahanara |
Susheela Tiwari Hospital |
Department of Anesthesiology, critical care, pain and palliative medicine
Nainital
UTTARANCHAL |
8868057120
dr.jahanara.malik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,GMC,HALDWANI |
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 |
Bupivacaine (heavy) 0.5% intrathecal |
Patients divided in 4 groups with group 4 getting 10mg (2ml) hyperbaric (0.5%) Bupivacaine intrathecally for subarachnoid block. |
| Comparator Agent |
Bupivacaine (heavy) 0.5% intrathecal with MORPHINE after Bupivacaine. |
Patients divided in 4 groups with group 2 getting 9 mg (1.8ml) hyperbaric (0.5%) Bupivacaine intrathecally with MORPHINE 200mcg (0.2ml) administered after Bupivacaine for subarachnoid block |
| Comparator Agent |
Bupivacaine (heavy) 0.5% intrathecal with MORPHINE and Bupivacaine as a mixture. |
Patients divided in 4 groups with group 2 getting 9 mg (1.8ml) hyperbaric (0.5%) Bupivacaine intrathecally with MORPHINE 200mcg (0.2ml) administered with Bupivacaine as a mixture for subarachnoid block |
| Comparator Agent |
Bupivacaine (heavy) 0.5% intrathecal with MORPHINE before Bupivacaine. |
Patients divided in 4 groups with group 3 getting 9 mg (1.8ml) hyperbaric (0.5%) Bupivacaine intrathecally with MORPHINE 200mcg (0.2ml) administered before Bupivacaine for subarachnoid block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
208 healthy full term non labouring parturients, ASA I -II (American Society of Anaesthesiologists Physical status grading system), with singleton pregnancy scheduled for both elective and caesarean (CS) under SAB are included in the study . |
|
| ExclusionCriteria |
| Details |
1. Complicated pregnancy
2. Multiple pregnancy
3. Pregnancy with bleeding disorders, spinal deformity, any other contraindication to SAB
4. Pregnancy with acute fetal distress
5. Intrauterine deaths or known fetal anomaly
6. Severe PIH (Pregnancy Induced Hypertension) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the block characteristics among the groups. |
The time of sensory block height and maximal cephalad height and onset of motor block and regression time will be noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the maternal hemodynamic and any intra-op and post-op complications among the groups. |
vitals will be monitored every 2 min for 20 mins and every 5 mins after 20 mins until 75 mins. |
To compare the VAS score and any additional analgesia requirement among the groups
|
VAS score will be assessed postoperatively at 2hr, 4hr, 12hr, 24 hr, then every day for a week. |
To compare the neonatal outcome among the groups.
|
APGAR score will be assessed at 1min, 5min, 10min. |
|
|
Target Sample Size
|
Total Sample Size="208"
Sample Size from India="208"
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)
|
30/07/2025 |
| 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="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
|
This study explores the impact of different methods of intrathecal administration of bupivacaine (0.5% heavy) with or without morphine during spinal anesthesia for caesarean section. Specifically, it compares:
Premixed administration (bupivacaine + morphine in the same syringe),
Sequential administration (morphine before or after bupivacaine),
Bupivacaine alone.
The primary focus is to determine whether the sequence of drug administration affects:
Quality and duration of anesthesia, Hemodynamic stability, Postoperative pain relief, rescue analgesia, Side effect profile.
208 parturients undergoing caesarean section under spinal anesthesia, divided into 4 groups of 52 each.
Groups:
1. Group I – Bupivacaine (9mg)(1.8ml) + morphine(200mcg)(0.2ml) premixed.
2. Group II – Bupivacaine(9mg)(1.8ml) first, followed by morphine(200mcg)(0.2ml) (sequential).
3. Group III – Morphine (200mcg)(0.2ml)) first, followed by bupivacaine (9mg)(1.8ml) (sequential).
4. Group IV – Bupivacaine(10mg)(2ml) only (control group).
All patients received standard preoperative fasting, IV access, premedication, and spinal anesthesia using 27G Quincke needle at L3-L4.
Hemodynamic parameters and block characteristics were recorded.
Pain was assessed using Visual Analogue Scale (VAS), motor block by Modified Bromage Scale, and sedation by Ramsay Sedation Score.
Postoperative monitoring included duration of analgesia, incidence of hypotension, bradycardia, respiratory depression, nausea, and any neurological complications.
The study seeks to determine the optimal technique for intrathecal drug administration to:
Prolong analgesia, enabling early ambulation and faster recovery,
Minimize complications (e.g., hypotension),
Improve postoperative outcomes, reduce hospital stay,
Provide evidence-based guidance for better obstetric anesthesia practices. |