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CTRI Number  CTRI/2021/02/030906 [Registered on: 01/02/2021] Trial Registered Prospectively
Last Modified On: 29/01/2021
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 clinical trial to study the effects of two pain relief drugs, fentanyl and buprenorphine added to chloroprocaine, a numbing drug injected at the lower back into a space that carries nerves in patients undergoing operations around anus 
Scientific Title of Study   A prospective randomised double blind study of fentanyl and buprenorphine as an adjuvant to intrathecal chloroprocaine for short duration 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  Dr Anbu Murugaraj A 
Designation  Associate Professor 
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, Kancheepuram District Tamilnadu, India 603319

Kancheepuram
TAMIL NADU
603319
India 
Phone  9790837580  
Fax  044-27528305  
Email  dranbu2k1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Sekar G 
Designation  Assitant Professor  
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, Kancheepuram District Tamilnadu, India 603319

Kancheepuram
TAMIL NADU
603319
India 
Phone  9843136969  
Fax  044-27528305  
Email  arun1834@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Arun Sekar G 
Designation  Assitant Professor  
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, Kancheepuram District Tamilnadu, India 603319

Kancheepuram
TAMIL NADU
603319
India 
Phone  9843136969  
Fax  044-27528305  
Email  arun1834@yahoo.co.in  
 
Source of Monetary or Material Support  
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, Kancheepuram District Tamilnadu, India 603319 
 
Primary Sponsor  
Name  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Melmaruvathur, Kancheepuram District Tamilnadu, India 603319 
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 Anbu Murugaraj A  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  Department of Anaesthesiology, Operation theatre No.6 and Post operative recovery room, Operation theatre complex, B zone, First floor, Hospital Block
Kancheepuram
TAMIL NADU 		 9790837580

dranbu2k1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  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  Buprenorphine as additive to intrathecal choloroprocaine  75 micrograms Buprenorphine (0.5 ml) as additive to intrathecal 1% choloroprocaine 30mg (3ml) for patients undergoing short duration perianal surgeries 
Comparator Agent  Fentanyl as additive to intrathecal choloroprocaine   25 micrograms Fentanyl (0.5 ml) as additive to intrathecal 1% choloroprocaine 30 mg (3ml) for patients undergoing short duration perianal surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18-60 years
American Society of Anaesthesiologists (ASA) physical status I and II
Male and female
Patients undergoing subarachnoid block in elective perianal surgeries lasting for less than 60 minutes.
BMI <35
 
 
ExclusionCriteria 
Details  Patient refusal
Patients with local infection at the site of injection
Patients with known or ascertained hypersensitivity to local anaesthesia
Patient with coagulopathy, bleeding disorders and/or on treatment with anti-coagulants
Pregnant women and lactating women
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative analgesia using VAS Pain scale  Postoperative period, 2nd ,4th, 6th, 8th, 12th,16th, 20th and 24th hour 
 
Secondary Outcome  
Outcome  TimePoints 
Return to bromage score 0   Postoperative period upto 4 hours 
Hemodynamic parameters ( Heart rate, Mean arterial pressure, Oxygen saturation)  Baseline, 2 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes, 420 minutes, 480 minutes, 540 minutes, 600 minutes, 660 minutes, 720 minutes, 780 minutes, 840 minutes, 900 minutes and 960 minutes 
Time to void  Postoperative period upto 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   N/A 
Date of First Enrollment (India)   01/02/2021 
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   NIL. Will be published after completion of the study  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  arun1834@yahoo.co.in

  6. For how long will this data be available start date provided 01-03-2021 and end date provided 01-03-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomised double blind trial comparing the effectiveness of adding Burprenorphine and Fentanyl to intrathecal Chloroprocaine for short duration perianal surgeries that will be conducted in Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research. Primary outcome will be postoperative analgesia. Secondary outcomes will be return to bromage score 0, hemodynamic parameters ( Heart rate, Mean arterial pressure and Oxygen saturation) and time to void. 
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