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CTRI Number  CTRI/2024/04/065646 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the clinical features of two drug combinations for injecting into backbone , such as ropivacaine 0.75% with fentanyl and ropivacaine 0.75% with morphine on patients undergoing day care surgeries in the anal region  
Scientific Title of Study   A comparative study of intrathecal (0.75%) ropivacaine with fentanyl and intrathecal (0.75%) ropivacaine with morphine in day care perianal surgeries.  
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 Shirley Paulina 
Designation  Senior resident 
Affiliation  DR B R Ambedkar medical college and hospital Bengaluru 
Address  Dept. of anesthesia DR B R Ambedkar medical college and hospital Bengaluru 560045

Bangalore
KARNATAKA
560045
India 
Phone  9482218232  
Fax    
Email  shirlzz7291@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shirley Paulina 
Designation  Senior resident 
Affiliation  DR B R Ambedkar medical college and hospital Bengaluru 
Address  Dept. of anesthesia DR B R Ambedkar medical college and hospital Bengaluru 560045

Bangalore
KARNATAKA
560045
India 
Phone  9482218232  
Fax    
Email  shirlzz7291@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shirley Paulina 
Designation  Senior resident 
Affiliation  DR B R Ambedkar medical college and hospital Bengaluru 
Address  Dept. of anesthesia DR B R Ambedkar medical college and hospital Bengaluru 560045

Bangalore
KARNATAKA
560045
India 
Phone  9482218232  
Fax    
Email  shirlzz7291@gmail.com  
 
Source of Monetary or Material Support  
DR B R Ambedkar medical college and hospital Bengaluru 560045  
 
Primary Sponsor  
Name  Dr Shirley Paulina 
Address  Dept. of anesthesia DR B R Ambedkar medical college and hospital Bengaluru 560045 
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 
DR Shirley Paulina  DR B R Ambedkar Medical College Hospital KG halli Bengaluru  OT complex, Department of anesthesia,
Bangalore
KARNATAKA 
9482218232

shirlzz7291@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dr BR Ambedkar Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ropivacaine with fentanyl  1.5 ml of 11.25 mg of 0.75% ropivacaine with 0.5 ml of 25mcg of fentanyl given intrathecally. 
Intervention  ropivacaine with morphine  1.5 ml of 11.25 mg of 0.75% ropivacaine with 0.1 ml of 100 mcg of morphine with 0.4 ml of normal saline given intrathecally. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) Patients aged between 18 to 60 years of age posted for elective perianal surgeries.
b) ASA grade I and II patient 
 
ExclusionCriteria 
Details  a)Patients who has H/o coagulation and bleeding disorders.
b) Infection at the site of spinal anesthesia
c) H/o hypersensitivity to study drugs.
d) Patients not giving consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia in each group.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time to achieve S1 sensory block
2.Degree of motor block
3.Time taken for ambulation without assistance.
4.Complications if any 
24 hours  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/04/2024 
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="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  
Subarachnoid block is a popular anaesthesia procedure practiced worldwide. It is a standard procedure for lower abdominal, lower limb and perianal surgeries. It is a more reliable, quick procedure, applicable in emergency surgeries. An ideal anaesthetic for spinal anaesthesia in ambulatory surgery should provide rapid onset, adequate potency, predictable duration, decreased neurotoxicity along with minimal systemic side effects.
Ropivacaine has high pKa , low lipid solubility, it has great degree of sensory blockade and lesser duration of motor blockade compared to Bupivacaine. It also provides rapid sensorimotor dissociation. It is a favorable drug for day care surgeries. Adjuvants like Opioids when added to Ropivacaine have shown to prolong the duration analgesia after surgery.
Subarachnoid fentanyl is known to provide rapid onset of analgesia, improve surgical blockade quality and enhance the effect of small doses of subarachnoid local anaesthetic. Intrathecal morphine used as a ‘one-shot’ method provides several advantages as it is easy, cost-effective, and reliable, and technical failures are rare. The analgesic effects last for 20–48 h. Morphine results in cephalad spread, thereby increasing the area of analgesia.
 
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