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CTRI Number  CTRI/2021/07/035191 [Registered on: 27/07/2021] Trial Registered Prospectively
Last Modified On: 17/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing two drugs potency seperately and in combination along with drug used for anesthetising in arm surgeries on providing pain relief during and after surgery  
Scientific Title of Study   Comparison of Dexmedetomidine and Dexamethasone either individually or in combination as an additive to Ropivacaine for postoperative analgesia in Supraclavicular Brachial Plexus Block – A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Annushha Gayathri G 
Designation  Post Graduate Student 
Affiliation  Srm Medical College Hospital and Research Centre 
Address  Room no 16 B C Roy Hostel SRM Medical College Hospital and Research Centre Department of Anaesthesiology Potheri Kancheepuram TAMIL NADU 603203
Srm Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU
603203
India 
Phone  8939064666  
Fax    
Email  annu.gayu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Annushha Gayathri G 
Designation  Post Graduate Student 
Affiliation  Srm Medical College Hospital and Research Centre 
Address  Room no 16 B C Roy Hostel SRM Medical College Hospital and Research Centre Department of Anaesthesiology Potheri Kancheepuram TAMIL NADU 603203
Srm Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU
603203
India 
Phone  8939064666  
Fax    
Email  annu.gayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr R BALAJI 
Designation  PROFESSOR 
Affiliation  Srm Medical College Hospital and Research Centre 
Address  Department of Anaesthesiology SRM Medical College Hospital and Research Centre Potheri Kancheepuram Tamilnadu 603203
Srm Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU
603203
India 
Phone  9677053310  
Fax    
Email  aarbee79@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre, SRMIST, SRM nagar, Potheri, Kattankulathur, Kancheepuram district 603203 
 
Primary Sponsor  
Name  SRM Medical College Hospital and Research Centre 
Address  SRMIST SRM nagar Potheri 
Type of Sponsor  Research institution and hospital 
 
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 Annushha Gayathri G  SRM Medical College and Hospital  Room no 16 B C Roy Hostel Department of Anaesthesiology SRM Medical College and Hospital SRMIST Potheri Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 
8939064666

annu.gayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20 ml of 0.5% Ropivacaine with 50 mcg Dexmedetomidine (0.5ml) and 1 ml normal saline (GROUP DX) and 20 ml of 0.5% Ropivacaine with 4 mg Dexamethasone (1ml) and 0.5 ml normal saline (GROUP DM)  Using two other different drugs in addition to local anesthetic in performing Supraclavicular brachial plexus block 
Intervention  20 ml of 0.5% Ropivacaine with 50 mcg of Dexmedetomidine (0.5ml) and 4mg of Dexamethasone (1ml) (GROUP DD)  Using combination of Dexmedetomidine and Dexamethasone as an additive to local anesthetic drugs in supraclavicular brachial plexus blocks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with ASA Physical Status I and II posted for upper limb surgeries under supraclavicular brachial plexus blocks

Weighing between 50 – 100 kg
 
 
ExclusionCriteria 
Details  All patients with ASA Physical Status III and above
Patients who refuse to participate in the study
Patients who are allergic to amide local anesthetics
Patients who are pregnant
Patients with chronic renal, cardiac or hepatic condition
Patients with coagulation abnormalities
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia  24 hours postoperatively
 
 
Secondary Outcome  
Outcome  TimePoints 
1)Onset of sensory and motor block
2)Total amount of rescue analgesic used
3)Incidence of sedation bradycardia and hypotension
 
1) 24 hours postoperatively
2) 24 hours postoperatively
3) Till 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   02/08/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patients admitted in SRM Medical College Hospital & Research Centre posted for upper limb surgeries who fulfill the inclusion criteria will be enrolled in this study. Patients will be randomly allocated into three groups, Group DX, Group DM and Group DD, with 30 patients in each group based on computer generated random numbers. 

The anesthesiologist performing the block and observing the patient will be blinded to the treatment group to avoid observer bias. Group DX will receive 20 ml of 0.5% Ropivacaine with 50 mcg Dexmedetomidine (0.5ml) and 1 ml normal saline, DM will receive 20 ml of 0.5% Ropivacaine with 4 mg Dexamethasone (1ml) and 0.5 ml normal saline and group DD will receive 20 ml of 0.5% Ropivacaine with 50 mcg of Dexmedetomidine (0.5ml) and 4mg of Dexamethasone (1ml). The total volume of the drug solution is made to 21.5 ml.

All patients will be premeditated with Tab.Alprazolam 0.5 mg PO 2 hrs before being shifted to the operating theatre. Patient’s vitals will be monitored with pulse oximetry, NIBP and ECG.

            After taking proper aseptic precautions, under ultra sound guidance, Supraclavicular Brachial Plexus block will be given using 20 ml of 0.5% ropivacaine + 50 mcg dexmedetomidine (0. ml) and 1 ml normal saline in group DX, 20 ml of 0.5% ropivacaine + 4 mg dexamethasone (1ml) and 0.5 ml normal saline in group DM and group DD will receive 20 ml of 0.5% ropivacaine + 50 mcg of Dexmedetomidine (0.5ml) and 4mg of dexamethasone (1ml).

            Sensory evaluation will be done by pin prick with a 25 G needle at an interval of  5, 10, 15, 20 and 30 minutes. The entire cutaneous innervation of upper limb i.e. musculocutaneous, radial, ulnar, median and medial cutaneous nerves of arm (MCNA) will be tested individually.

                                2 Normal sensation

                                1 Hypoesthesia

                                0 No sensation felt

                     A score of 0 will be taken as time of onset of sensory block for that nerve. Site of surgical incision and sparing of incision site will be noted

                     Motor block is assessed after 5, 10, 15, 20 and 30 minutes after injection of the drug as per Lavoie and colleagues:

                                                                   0% - Flexion and extension in both the hand and arm against resistance

                                                                   33% - Flexion and extension in both the hand and arm against gravity but not against resistance

                                                                   66% - Flexion and extension movements in the hand but not in the arm

                                                                   100% - No movement in the entire upper limb

 Sedation score will be noted using Ramsay Scale

Level of Activity                                                                     Points

Patient anxious, agitated or restless                                           1

Patient co-operative, orientated and tranquil                              2

Patient responding only to verbal commands                             3

Patient with brisk response to light glabellar tap                        4                               

or loud auditory stimulus

Patient with sluggish response to light glabellar tap                   5                

or loud auditory stimulus                                                         

Patient with no response to light glabellar or loud

auditory stimulus                                                                         6

                                                             The need for intra-operative supplementary systemic medication or general anaesthesia and adverse effects (namely vessel puncture, seizures, newly observed cardiac arrhythmias, oxygen saturation lower than 90%, signs of local anaesthetic toxicity, unintentional paresthesia) will be recorded. Failed blocks will be converted to general anaesthesia and will be excluded from the study. All patients will be post operatively monitored in the post anaesthesia care unit (PACU) for 24 hours and thereafter discharged to their wards.

Post-operative pain at the incision site will be  assessed by visual analogue pain scale (VAS), a score of more than 3 when recorded will be  taken as duration of post op analgesia and the patient will be  given supplementary analgesics i.e. Inj. Paracetamol 1000 mg (iv). If the patient elicits a VAS score of more than 6, Inj. Tramadol 100 mg (iv) will be administered as rescue analgesic.

 
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