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CTRI Number  CTRI/2024/02/063007 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the clinical features of drugs 0.75% ropivacaine and the combination of ropivacaine 0.75% with fentanyl 25 mcg for spinal anaesthesia in patients undergoing perianal surgeries  
Scientific Title of Study   A comparative study Of intrathecal (0.75%) Ropivacaine and (0.75%) Ropivacaine with Fentanyl in daycare perianal surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARUN KUMAR A BARASAKALE 
Designation  POST GRADUATE RESIDENT 
Affiliation   
Address  OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045

Bangalore
KARNATAKA
560045
India 
Phone  7204602149  
Fax    
Email  arun.16evez@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M SALIM IQBAL 
Designation  PROFESSOR DEPARTMENT OF ANESTHESIOLOGY 
Affiliation  DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL 
Address  OT COMPLEX, DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045

Bangalore
KARNATAKA
560045
India 
Phone  9964651079  
Fax    
Email  drsalim_iqbal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  ARUN KUMAR A BARASAKALE 
Designation  POST GRADUATE RESIDENT 
Affiliation  DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL 
Address  OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045

Bangalore
KARNATAKA
560045
India 
Phone  7204602149  
Fax    
Email  arun.16evez@gmail.com  
 
Source of Monetary or Material Support  
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045  
 
Primary Sponsor  
Name  Dr ARUNKUMAR A BARASAKALE 
Address  OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045 
Type of Sponsor  Other [] 
 
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 
DRARUNKUMAR A BARASAKALE  DR.ARUNKUMAR. A. BARASAKALE   OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R.AMBEDKAR MEDICAL COLLEGE HOSPITAL, KADUGONDANAHALLI, BANGALORE – 560045 Bangalore KARNATAKA
Bangalore
KARNATAKA 
7204602149

arun.16evez@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   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 
Intervention  Ropivacaine  Spinal block characters  
Comparator Agent  Ropivacaine with fentanyl  Spinal block characteristics  
 
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) Local site infections.
c) H/o hypersensitivity to study drugs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Time taken for ambulation without assistance.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time to achieve T10 sensory block
2.Maximum height of sensory block
3.Duration of sensory block
4.Duration of motor block 
24 HOURS  
 
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 1 
Date of First Enrollment (India)   03/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 (SAB) is most widely used regional anesthesia technique in the world. It is a reliable, quick, effective and safe technique with predictable benefits, and has been the procedure of choice for perianal surgeries unless contraindicated.  The changing trend of surgical practice from an inpatient to outpatient has urged us to use short duration acting local anesthetic.
An ideal anesthetic for spinal anesthesia in ambulatory
surgery should provide rapid onset, adequate potency, predictable duration, decreased neurotoxicity along with minimal systemic side effects.The evidence for transient neurological symptoms (TNS) associated with the short-acting spinal anesthetic lidocaine has led to the use of alternative drugs such as bupivacaine, levobupivacaine or ropivacaine. Ropivacaine is the pure S enantiomer of propivacaine and is a amide local anaesthetic which is associated with a lower grade of motor block, a shorter duration of action than bupivacaine and a reduced potential for CNS and cardiac toxicity, making it a possible alternative to lidocaine for shorter outpatient procedures.
The dose of local anesthetic  can be reduced by the addition of adjuvant like opioids and alpha 2 adrenergic agonists.
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.
We hypothesise that addition of fentanyl to ropivacaine as neuraxial adjuvant improves the quality of spinal block and prolongs postoperative analgesia without significantly prolonging the time for ambulation without assistance.
 
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