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CTRI Number  CTRI/2024/11/076802 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A study to evaluate the effectiveness of intravenous dexmedetomidine infusion on frmoro-sciatic nerve blocks for below knee surgeries 
Scientific Title of Study   Effect of intravenous dexmedetomidine infusion on femoro-sciatic nerve block in below knee surgeries: a randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
02  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GOKULNATH THANGARAJ 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 India

Imphal West
MANIPUR
795004
India 
Phone  8220995170  
Fax    
Email  gokulnatht97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N RATAN SINGH 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 India

Imphal West
MANIPUR
795004
India 
Phone  7005218909  
Fax    
Email  drnratansingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr N RATAN SINGH 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 India


MANIPUR
795004
India 
Phone  7005218909  
Fax    
Email  drnratansingh@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal- 795004, Manipur, India 
 
Primary Sponsor  
Name  GOKULNATH THANGARAJ 
Address  Regional Institute of Medical Sciences, Lamphelpat, Imphal- 795004, Manipur, India 
Type of Sponsor  Other [Post Graduate Trainee] 
 
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 
GOKULNATH THANGARAJ  Regional Institute of Medical Sciences, Imphal West, Manipur  Elective surgery Operation theatre complex (OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur, India
Imphal West
MANIPUR 		 8220995170

gokulnatht97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, Regional institute of Medical Sciences, Imphal, Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Study participants will be randomized into two groups. Intervention group will receive 40 ml of 0.375% perineural ropivacaine (femoro-sciatic nerve blocks) with with 0.5mcg/kg of dexmedetomidine in a volume of 20ml over 10 minutes as intravenous infusion.  
Comparator Agent  Normal saline   Study participants will be randomized into two groups. Comparator group will receive 40 ml of 0.375% perineural ropivacaine (femoro-sciatic nerve blocks) with 20 ml of Normal saline as intravenous infusion over 10 mins  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of age group 18 to 60 years.
2. Patients of American Society of
Anaesthesiologists (ASA) physical grade I or II.
 
 
ExclusionCriteria 
Details  1. Hypersensitivity to the amide group of local
anaesthetic agents and dexmedetomidine.
2. Patients having hypertension/diabetes mellitus
/ neuropathy / peripheral nerve injury
3. Pregnancy and lactation
4. Patient on anticoagulants or bleeding disorder
5. Patients having problems in communication
6. Infection at the site of drug injection.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to access the Motor and Sensory Block characteristics  Outcome will be assessed from the point of
administration of femoro-sciatic nerve block till 24hrs after the surgery. Data will be then
assessed at the end of two years. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   25/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This study will be a randomized double blinded, prospective, comparative study, to be carried out in 52 patients of ASA I and II undergoing below knee surgery with               combined femoral and sciatic nerve block (popliteal-sciatic approach).

The patients will be randomly divided into two groups of 26 each. Group B (n=26) will receive inj. 0.375% Ropivacaine (40ml) with 20ml of intravenous infusion of                 dexmedetomidine over 10minuets. Group A (n=30) will receive inj. 0.375% Ropivacaine (40ml) with intravenous infusion 20ml of Normal Saline over 10 minuets.

The onset and duration of sensory block and motor block, duration of analgesia or time to first rescue analgesic request (TFAR) and side effects will be assessed                 and recorded.

All the findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference drawn              to evaluate and compare the two groups on sensory and motor block onset and duration .

 
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