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CTRI Number  CTRI/2024/10/075010 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clonidine vs. Pain: A Comparative Study of Clonidine Administration Routes as an adjuvant for Post-Operative Analgesia after ACL Repair 
Scientific Title of Study   Comparison of different routes of administration of Clonidine as an adjuvant For Post-operative analgesia following Anterior Cruciate Ligament Repair 
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 Grace Mammen 
Designation  Junior Resident 
Affiliation  Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune 
Address  Department of Anaesthesiology Dr. D.Y. Patil Vidyapeeth (Deemed University) Padmashree Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7776904947  
Fax    
Email  gracepune7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheetal Jayakar 
Designation  Professor 
Affiliation  Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune 
Address  Department of Anaesthesiology Dr. D.Y. Patil Vidyapeeth (Deemed University) Padmashree Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone    
Fax    
Email  sheetaljayakar2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Grace Mammen 
Designation  Junior Resident 
Affiliation  Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune 
Address  Department of Anaesthesiology Dr. D.Y. Patil Vidyapeeth (Deemed University) Padmashree Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7776904947  
Fax    
Email  gracepune7@gmail.com  
 
Source of Monetary or Material Support  
Dr DY Patil Medical College, Hospital and Research Centre, Pimpri, Pune 
 
Primary Sponsor  
Name  Dr Grace Mammen 
Address  Department of Anaesthesiology Dr. D.Y. Patil Vidyapeeth (Deemed University) Padmashree Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune  
Type of Sponsor  Other [self] 
 
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 Grace Mammen  Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune.  Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune – 411018.
Pune
MAHARASHTRA 		 7776904947

gracepune7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Sub-Committee, Dr DY Patil Medical College, Pune   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, (2) ICD-10 Condition: S835||Sprain of cruciate ligament of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj clonidine as adjuvant in Adductor Canal Block (ACB).   20ml of Inj. Bupivacaine 0.25% + 0.5µg/kg clonidine in Adductor Canal Block (ACB).  
Comparator Agent  intrathecal adjuvant Inj. Clonidine   addition of 0.5µg/kg of Inj. Clonidine to 2.5cc of Inj. Hyperbaric Bupivacaine 0.5% given intrathecally  
Comparator Agent  plain intrathecal block without clonidine  2.5 ml of 0.5% Inj. Hyperbaric Bupivacaine intrathecally.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  18-75 years aged patients
BMI 20-35 kg/m2
ASA I – II
Availability of written informed consent Hemodynamically stable patients with all routine investigations within normal limits.
Patients undergoing arthroscopic ACL repair  
 
ExclusionCriteria 
Details  Patient unwilling to get enrolled in the study. Allergy to the study drugs.
Patient with pre-op Heart rate 45 beats/min or less.
Patient on recent oral opioids in last 3 months. Patients in whom the nerve block could not be performed as per methodology
Patients with contraindications to Spinal Anaesthesia
Pregnancy
Any cognitive dysfunction or psychiatric disorders Patient with heart diseases like congestive heart failure, coronary heart disease, any degree of tract block.
Patient with renal insufficiency or liver impairment.
Patient with coagulopathy.
Patient with neuropathy.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to assess duration of analgesia (time till Visual Analogue Score more than 3)  measuring visual analogue scores (VAS) immediately post block every 15 mins in the first hour followed by every 2 hours post block for first 6 hours, then every 6 hours till VAS more than three  
 
Secondary Outcome  
Outcome  TimePoints 
to assess pain score post operatively   measuring visual analogue pain scores immediately post block till twenty-four hours post block  
duration of sensory blockade  measuring skin prick scores from immediately post block till score of two achieved (till return of sensation at knee joint) 
duration of motor block  measuring modified Bromage score from immediately post block till score of four achieved (ability to flex knee joint) 
sedation  measure ramsay sedation scores at 15 minute intervals till baseline levels achieved 
patient satisfaction score  measured at twenty-four hours post block 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   09/10/2024 
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="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   Anterior Cruciate Ligament (ACL) Repair is one of the most common orthopaedic sports surgeries today. Post-operative pain is the most common complication that delays early ambulation and patient discharge, thereby increasing hospitalization costs as well. Therefore, effective postoperative analgesia is of great significance. 
ACL surgeries are now commonly done under regional anaesthesia i.e. neuraxial or peripheral nerve blocks using local anaesthetics. 
Several adjuvants have been used to further prolong the analgesic duration of local anaesthetic agents in the above methods like Clonidine, Dexamethasone.
Clonidine not only has analgesic properties but also extends the action of local anaesthetics, reducing the required analgesic dose and helping prevent local toxicity at the injection site. 
In this study we evaluated different routes of administering Clonidine as an adjuvant for prolonging post-operative analgesia in patients undergoing ACL surgeries.
33 patients of either sex, in age group of 18-75 years posted ACL repair surgeries were randomly divided into 3 groups of 11 each,
•Group SC (Standard Care Group) which received plain intrathecal block.
•Group IT (Intrathecal Clonidine Group) which received intrathecal block with clonidine as adjuvant.
•Group NB (Nerve Block with Clonidine Group) which received clonidine as adjuvant in Adductor canal block (ACB) in addition to plain intrathecal block.
Post block patients were evaluated for duration of analgesia and duration of sensory and motor blockade.
This study demonstrates that Clonidine, when used as an adjuvant, significantly prolongs postoperative analgesia in both intrathecal and peripheral block routes. 
Notably, it demonstrates greater efficacy in Peripheral Nerve Blocks compared to the intrathecal route.
 
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