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CTRI Number  CTRI/2025/09/095269 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Randomised controlled trial]  
Study Design  Other 
Public Title of Study   Comparing combination of two drugs namely 0.25 percent Ropivacaine and Dexmedetomidine when used with Clonidine in nerve blocks to compare pain relief in patients aged 18 to 64 yrs who are posted for shoulder arthroscopic surgeries  
Scientific Title of Study   Comparison of 0.25 percent Ropivacaine with Dexmedetomidine vs Clonidine as an adjuvant in Interscalene Brachial plexus block for post operative analgesia in shoulder arthroscopy. 
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 Sandra Monis 
Designation  Post graduate 
Affiliation  St. Johns Medical College and Hospital, Bangalore 
Address  Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034
Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034
Bangalore
KARNATAKA
560034
India 
Phone  7022474598  
Fax    
Email  sandramonis9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nischala Dixit 
Designation  Professor Department of Anaesthesia St. Johns Medical College Hospital  
Affiliation  St. Johns Medical College and Hospital, Bangalore 
Address  Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034
Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034
Bangalore
KARNATAKA
560034
India 
Phone  9535148078  
Fax    
Email  drnischala01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandra Monis 
Designation  Post graduate 
Affiliation  St. Johns Medical College and Hospital, Bangalore 
Address  Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034
Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034
Bangalore
KARNATAKA
560034
India 
Phone  7022474598  
Fax    
Email  sandramonis9@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia and Critical Care St. Johns Medical College and Hospital, Bengaluru-560034 
 
Primary Sponsor  
Name  ST JOHNS MEDICAL COLLEGE AND HOSPITAL 
Address  OT Complex, 2nd floor, St. Johns Medical and Hospital, Sarjapur-Marathahalli Rd,beside Bank of Baroda, John Nagar, Koramangala Bengaluru-560034 
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 Sandra Monis  St. Johns Medical College and Hospital   OT Complex, 2nd floor St. Johns Medical College and Hospital Sarjapura road Koramangala Bengaluru-560034
Bangalore
KARNATAKA 
7022474598

sandramonis9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St. Johns 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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1 - Inj 0.25 % Ropivacaine + Clonidine  Patients randomised into group 1 will receive an interscalene brachial plexus block with 0.25 percent Ropivacaine plus Clonidine. 
Comparator Agent  Group 2 - Inj 0.25 % Ropivacaine + Dexmedetomidine  Patients randomised into group 2 will receive an interscalene brachial plexus block with 0.25 percent Ropivacaine plus Dexmedetomidine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1) Age group- 18 - 59years,
2) Scheduled for elective shoulder arthroscopic surgeries under GA
3) ASA Grade I and II patients
 
 
ExclusionCriteria 
Details  1) Patient refusal
2) Bleeding disorders
3) Patients with known local anesthetic sensitivity
4) morbidly obese patients
5) Previous h/o upper limb nerve damage
6) Respiratory insufficiency
7) Infection at the block location.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of 12 ml of 0.25% Ropivacaine + Dexmedetomidine vs 12 ml of 0.25% Ropivacaine + Clonidine on duration of analgesia when used in Interscalene Brachial Plexus block for shoulder arthroscopy.  Postoperatively VAS scores of patients will be assessed for 2,4,6,8,10,12,24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1)VAS Score over 24 hours
2)Time to first request of post operative analgesia
3)Total IV PCA Fentanyl consumption over 24 hrs
 
Vas score will be assessed at 2,4,6,8,10,12,24 hrs post block 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   06/10/2025 
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="2"
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  

Introduction

 Arthroscopy is one of the greatest advancements in the field of orthopaedic surgery. The advent of such a minimal invasive procedure made away with the need for standard open surgical techniques resulting in a decrease in post op complications thereby facilitating faster recovery. Shoulder Arthroscopy, the second most performed orthopaedic procedure is now employed to treat a myriad of pathologies like labral tears, rotator cuff tears, adhesive capsulitis, subacromial impingement, degenerative arthritis, proximal biceps pathology, loose bodies etc. It also offers a comprehensive view of intraarticular pathologies if any. A study on patient perception of shoulder arthroscopy vs open techniques showed that a vast majority of patients perceived the former to be superior to open surgery in terms of functional outcome.  However, shoulder arthroscopic surgeries are reputed to produce intense post operative pain. This is usually circumvented by administering blocks like Inter scalene block which is reported to deliver excellent post-operative analgesia. It is a type of regional anaesthesia that targets the Brachial Plexus, a complex network of nerves originating from the cervical spine, and is performed with local anaesthetics, the choice of which is determined by the magnitude and duration of surgery. Long-acting drugs such as Ropivacaine or Levobupivacaine are usually employed for most surgeries.  The block can be further enhanced by using adjuvants like Adrenaline, Soda bicarbonate, Clonidine, Buprenorphine, Dexamethasone and Dexmedetomidine.

 Dexmedetomidine is a highly selective a2-adrenergic agonist that inhibits Norepinephrine release, leading to enhanced analgesia and sedation. Compared to clonidine, it provides a more potent and controlled sedation, along with a faster onset of action. Clonidine, which also functions as an a2-adrenergic agonist shares a similar mechanism of action but has a more prolonged duration of action. However, its sedative and analgesic effects tend to be less pronounced than those of Dexmedetomidine.


Methodology

·       The study will be non blinded and will be conducted after obtaining approval from the Institutional Ethics Committee (IEC) and written informed consent of patients.

                           

·       42 patients of ASA grades 1 and 2 aged between 18-59 years of age undergoing shoulder arthroscopic surgeries will be included in this study and will be divided into two groups by simple randomisation in a 1:1ratio based on a computer-generated sequence - Group 1 and Group 2.

 

·       Detailed Pre- anaesthetic evaluation and relevant investigations will be done for each patient following which written informed consent will be taken.

·       The patients will be kept Nil per oral- 6 hours for solids and 2 hours for clear liquids.

·       In the operation theatre Standard monitors including electrocardiography (ECG), non-invasive blood pressure (NIBP) and pulse oximetry (SPO2) will be connected and vitals will be monitored.

·       Patients will be preoxygenated with 100% oxygen for 3 min, followed by induction with Propofol 2 mg/kg intravenously and Atracurium 0.5 mg/kg to facilitate endo tracheal intubation. Patient will be maintained on general anaesthesia with Isoflurane/O2/air mixture With a MAC value of 1.2. Muscle relaxation will be provided by intermittent boluses of Atracurium.

·       Following intubation, the patient’s head will be turned 30 degrees away from the side to be blocked and ipsilateral arm will be kept in adducted position. Supraclavicular fossa and surrounding area will be painted in circular motions and draped.

·       The block will be performed by a practitioner who has given a minimum of 20 USG guided supraclavicular blocks in the past.

·       Linear USG probe will be applied in supraclavicular fossa to visualize the brachial plexus posterolateral to the subclavian artery

·       Local infiltration at site of needle entry with 1 mL of 2% Lignocaine.

·       In both the groups, local anaesthetic drug used will be a mixture of 12ml of 0.25% Ropivacaine  .

 

Group 1 (Clonidine) –  Clonidine (1mcg/kg)  + 12 ml of Inj 0.25 % Ropivacaine

Group 2 (Dexmed)- Dexmedetomidine (1mcg/kg) +12 ml of Inj 0.25 % Ropivacaine

 

The primary outcome of this study is duration of analgesia which will be assessed as the time interval between extubation and the patient’s first request for pain relief:  VAS scores will be measured at 2, 4, 6, 8, 10, 12 and 24 hours postoperatively. When post op VAS score>6, Inj. Fentanyl will be given as a rescue analgesic.

 
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