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CTRI Number  CTRI/2025/03/081588 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of different dilution methods of intrathecal morphine in patients undergoing elective caesarean section 
Scientific Title of Study   The effect of different dilution methods of intrathecal morphine on post operative nausea, vomiting and pruritus in patients undergoing elective casearean 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  V B S HRULLEKHA  
Designation  Junior resident  
Affiliation  Jss medical college and hospital 
Address  Department of anaesthesiology,Jss medical college and hospital ,mysuru,karnataka,570004.

Mysore
KARNATAKA
570004
India 
Phone  8074733767  
Fax    
Email  hrullekhavbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil kumar 
Designation  Professor 
Affiliation  Jss medical college and hospital  
Address  Department of Anesthesia,Jss medical college and hospital Mysore Karnataka

Mysore
KARNATAKA
570004
India 
Phone  9945155844  
Fax    
Email  dranilkumarmr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anil kumar 
Designation  Professor 
Affiliation  Jss medical college and hospital  
Address  Department of Anesthesia,Jss medical college and hospital Mysore Karnataka

Mysore
KARNATAKA
570004
India 
Phone  9945155844  
Fax    
Email  dranilkumarmr@gmail.com  
 
Source of Monetary or Material Support  
Jss medical college and hospital,mahatma gandhi road,fortmohalla,mysuru,karnataka,570004 
 
Primary Sponsor  
Name  Jss academy of higher education and research center  
Address  Jss medical college and hospital,mysuru,570004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
V B S HRULLEKHA   Jss medical college and hospital  Pregnant females posted for elective cesarean section in 2nd floor OT complex, JSS HOSPITAL, MG ROAD, AGRAHARA, MYSURU, KARNATAKA, 570004
Mysore
KARNATAKA 		 8074733767

hrullekhavbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jss academy of higher education and research center   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable   Not applicable  
Comparator Agent  The effect of different dilution methods of intrathecal morphine  Lumbar puncture is done with quincke spinal needle and spinal anaesthesia is given with 0.5% hyperbaric bupivacaine 10mg along with morphine 0.1mg, 1] one gradation of 10mg/ml of morphine is taken In 5cc syringe and dilated with 0.9% of normal saline to make it 5ml so that each ml contains 200mcg and half ml will have 100mcg. 2] one ml of 10mg/ml of morphine that is taken in 10cc syringe and diluted with 9ml of 0.9% normal saline to make it 10ml so that each ml contains 1mg and one ml of this solution is taken in 5cc syringe and diluted further with 4ml of 0.9% saline so that each ml contains 200mcg and half ml contains 100mcg, 3] one ml of morphine is taken In insulin syringe so that one unit contains 250mcg of morphine ,this two units of morphine is taken in 3cc syringe and diluted with 2.5ml of 0.9% normal saline so that final solution has 200mcg and half of it has 100mcg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Adults of ASA physical status II aged 18 to 45 years with gestational age between 37-42 weeks planned for elective cesarean section.

Parturients of height 150cm-170cm 
 
ExclusionCriteria 
Details  1] Multiple pregnancy
2] Patients with known history of pregnancy induced hypertension and gestational diabetes mellitus
3] Any contraindications to spinal anaesthesia
4] Patients with known allergy to bupivacaine and morphine 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of intrathecal morphine on pruritus and post operative nausea,vomiting.   1] post operative nausea,vomiting is recorded hourly for the first four hours and then fourth hourly for the next twenty four hours using three point ordinal scale.
2] Pruritus will be recorded every four hours for twenty four hours after surgery on a four point categorical scale. 
 
Secondary Outcome  
Outcome  TimePoints 
1] To assess the postoperative pain
2] To assess for other opiod side effects  		 Pain intensity measured on100mm VAS after surgery  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   14/03/2025 
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="6"
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  

Parturients planned to undergo elective cesarean section will be evaluated

                               

Patients will be selected based on inclusion criteria

                                

Informed and written consent will be taken from the study participants

 

On the day of surgery patients are shifted to the operation tteatre and monitors are connected

 

Spinal anaesthesia is given with inj.bupivacaine 0.5%(Heavy) of dose 10 mg along with morphine 0.1mg .

 

GROUP A : WILL BE RECEVING : One gradation of 10 mg/ml of  morphine that is taken in 5cc syringe[1mg of morphine] and diluted with 0.9% of Normal saline to make it 5ml so that each ml contains 200mcg , and half ml will have 100mcg.[ one step method]

GROUP - B : WILL BE RECEVING: One ml of 10mg/ml of morphine that is taken in 10cc syringe [10mg of morphine] and diluted with 9ml of 0.9% Normal saline to make it 10ml so that each ml contains 1mg , and one ml of this solution is taken in 5cc syringe and diluted further with 4ml of 0.9% of Normal saline , so that each ml contains 200mcg and half ml will have 100mcg.[two step method].

GROUP - C : WILL BE RECEVING: One ml of morphine [10mg/ml] that is taken in insulin syringe [1ml =40 units] , so that  1 unit will contain 250 mcg of morphine . This 2 units of morphine is taken in 3cc syringe and diluted with 2.5ml of 0.9% of Normal saline , so the final solution w ill have 200 mcg/ml and half ml will contain 100mcg.[ insulin syringe method].

 

 

Assessment of hemodynamics, motor block and sensory block

 

Intraoperative monitoring of HR, BP, SpO2, ECG at intervals of every minute for the first 5 min and every 3 min for rest of the surgery.

 

 

Patient will be shifted to PACU and monitored for post-operative nausea,vomiting and pruritus for every hour for first 4 hours and every 4 hrs for the next 24 hrs .

 

 
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