FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064709 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare different doses of dexmedetomidine combined with ropivacaine to assess postoperative analgesia using ultrasound guided supraclavicular brachial plexus block in upper limb surgeries 
Scientific Title of Study   A Randomized comparative study to Compare different doses of Dexmedetomidine combined with Ropivacaine to assess post-operative analgesia using ultrasound-guided Supraclavicular Brachial Plexus Block in Upper Limb Surgeries- in Department of Anaesthesia at SMS Hospital, Jaipur 
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 Poonam Kalra 
Designation  SENIOR PROFESSOR 
Affiliation  SMS medical college jaipur 
Address  Department of Anaesthesia sawai man singh medical college, jaipur, rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9413416787  
Fax    
Email  poonamkalra24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Tewatia 
Designation  JUNIOR RESIDENT  
Affiliation  SMS medical college jaipur  
Address  Departtment of Anaesthesia SMS medical college, Dhanwantri block, JLN Marg jaipur, rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  8053075272  
Fax    
Email  Nehatewatia94@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Poonam Kalra 
Designation  SENIOR PROFESSOR 
Affiliation  SMS medical college jaipur  
Address  Departtment of Anaesthesia SMS medical college, Dhanwantri block, JLN Marg jaipur, rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9413416787  
Fax    
Email  poonamkalra24@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia sawai man singh medical college jaipur  
 
Primary Sponsor  
Name  Department of anaesthesia sawai man singh medical college jaipur  
Address  Department of anaesthesia sawai man singh medical college jaipur rajasthan 302004 
Type of Sponsor  Government 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 Poonam Kalra  Sawai man singh medical colllege jaipur rajasthan  Departtment of Anaesthesia Dhanwantri block SMS medical college JLN Marg jaipur rajasthan rajasthan
Jaipur
RAJASTHAN 		 9413416787

poonamkalra24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE JAIPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V00-Y99||External causes of morbidity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  50mcg dexmedetomidine  Dexmedetomidine 50mcg combined with ropivacaine to assess the duration of analgesia using ultrasound guided supraclavicular brachial plexus block in upper limb surgery 
Intervention  ultasound guided supraclavicular brachial plexus block in elective upper limb surgery  dexmedetomidine 25mcg combined with ropivacaine to assess postoperative duration of analgesia using ultrasound guided supraclavicular brachial plexus block in upper limb surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient posted for upper limb surgeries
2. Either sex
3. Age-between 18 and 60 years
4. American Society ofAnesthesiologists Physical Status (ASA‑PS) Classes I and II
5.Bodyweight: 40-70 kg
6.Patients who will give informed written consent 
 
ExclusionCriteria 
Details  1.Patient should not be a part of other study.
2.Nonco-operative patient.
3.Patients having severe systemic illness and bleeding disorders,
4.Pregnant women
5.Patients allergic to study drugs
6.Patients havingpre-existing sensory and motor deficit
7.Local site infection or deformity if any at the injection site 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Mean Duration of analgesia (minutes)
2.Mean of NRS score
 		 Postoperative 4hr
Postoperative 8hr
Postoperative 12hr
Postoperative 16hr
Postoperative 20hr
Postoperative 24hr
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean time of onset of sensory block (minutes)
2.Mean time of onset of motor block (minutes)
3.Mean Duration of motor block (minutes)
4.Median of sedation score
5.Mean systolic B.P, mean diastolic B.P, Mean of mean B.P, Mean heart rate
6.Proportion of cases having adverse effects if any in both the groups 		 0min
5min
10min
15min
20min
25min
30min
45min
60min
75min
90min
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/03/2024 
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="0"
Months="3"
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    Supraclavicular brachial plexus block has been the choice of anaesthesia for upper limb surgeries .The addition of adjuvant to local anesthetic not only augments the anaesthetic action of the drug but also reduces the dose required thus improving the safety margin. Prolonging postoperative analgesia using various adjuvants has become a trend in regional anesthesia practice .which provides effective pain relief during intra operative and early postoperative period along with avoiding the risks of general anaesthesia.
In this study, we plan to compare different doses of Dexmedetomidine combined with Ropivacaine to determine their effectiveness in prolonging sensory and motor block and duration of analgesia in patients undergoing upper limb surgeries .For this a total of seventy patients (n=70) undergoing elective ultrasound-guided supraclavicular brachial plexus block who satisfy the inclusion criteria will be randomly divided into two groups of 35 each (A and B). Group A patients will be receiving Perineural: 20ml 0.5% ropivacaine + 25mcg Dexmedetomidine diluted in 1ml NS (total-21ml)for ultrasound-guided supraclavicular brachial plexus blockand group B will be receiving Perineural: 20ml 0.5% ropivacaine + 50mcg Dexmedetomidine diluted in 1ml NS (total-21ml) for ultrasound-guided  supraclavicular brachial plexus block.
When patients arrive in the operating room(OR), intravenous cannula (IV cannula) will be inserted and hemodynamic variables will be measured. After this ultrasound-guided supraclavicular brachial plexus block will be administered using different doses of dexmedetomidine as an adjuvant to Ropivacaine in groupA and groupB. Surgery will be allowed to proceed after the adequate effect is achieved. Quantitative values of time of onset of sensory loss, time of onset of motor loss, time taken for motor regression, duration of post operative analgesia, hemodynamic parameters, sedation score and side effects if any will be recorded
 
Close