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CTRI Number  CTRI/2024/11/077119 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of single and double adjuvant drugs in nerve block of lower limb surgeries 
Scientific Title of Study   Comparison Of Perineural Dexamethasone And Dexmedetomedine Vs Dexamethasone Only As An Adjuvant In Ultrasound Guided Sciatic Nerve Block Via Popliteal Approach In Orthopaedic Below Knee Surgeries A Double Blind Randomised Controlled Trial 
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 Sachin Kumar 
Designation  Assistant Professor AIIMS New Delhi 
Affiliation  all india institute of medical sciences 
Address  Room no 403, 4th Floor Surgical Block Department of Anesthesia, pain medicine & Critical care AIIMS New Delhi
Room no 403, 4th Floor Surgical Block Department of Anesthesia, pain medicine & Critical care AIIMS New Delhi
South West
DELHI
110029
India 
Phone  9871549343  
Fax    
Email  sk2007696@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sachin Kumar 
Designation  Assistant Professor AIIMS New Delhi 
Affiliation  all india institute of medical sciences 
Address  Room no 5011 Department of anesthesia , Pain Medicine & Critical Care anesthesia office 5th floor teaching block AIIMS New Delhi

South West
DELHI
110029
India 
Phone  9871549343  
Fax    
Email  sk2007696@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin Kumar 
Designation  Assistant Professor AIIMS New Delhi 
Affiliation  all india institute of medical sciences 
Address  Room no 403, 4th Floor Surgical Block, Department of Anesthesia, Pain Medicine & Critical Care ,AIIMS New Delhi
Room no 403, 4th Floor Surgical Block, Department of Anesthesia, Pain Medicine & Critical Care ,AIIMS New Delhi
South West
DELHI
110029
India 
Phone  9871549343  
Fax    
Email  sk2007696@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Dr Sachin kumar AIIMS NEW DELHI 
Address  Anesthesia Office 5th floor teaching block MAIN AIIMS , NeW Delhi  
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 SACHIN KUMAR  AIIMS New Delhi  Room no 403 4th floor Surgical Block All India Institute Of Medical Sciences New Delhi
South West
DELHI 
9871549343

sk2007696@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  dex group  one agent that is dexamethasone 4 mg will be added to 0.375 % ropivacaine to give popliteal sciatic nerve block 
Intervention  dex-dexmed group  Two agents that is dexamethasone 4mg and dexmeditomedine 20 mcg will be added to 15 ml of 0.375 % ropivacaine to give popliteal sciatic nerve block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age more than 18 years
2. Can provide consent
3. Below knee surgeries
4. ASA 1-3 physical status
 
 
ExclusionCriteria 
Details  1. Local site infection
2. Local anaesthetic allergy
3. Pre-existing neurological deficit in lower limb
4. Peripheral vascular disease
5. Bleeding diasthesis/coagulopathy
 
 
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 duration of analgesia in patients undergoing below knee surgeries under neuraxial blockade after administration of sciatic nerve block without adjunct, with dexamethasone (single adjunct) and with 2 adjuncts (dexamethasone and dexmedetomidine).  Post operative pain at 30 min., 2hour , 4 hour, 8 hour ,12 hour, 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the opioid requirements in patients undergoing below knee surgeries under neuraxial blockade after administration of sciatic nerve block without adjunct, with dexamethasone (single adjunct) and with 2 adjuncts (dexamethasone and dexmedetomidine).
2. To compare the side effects of sciatic nerve block with no adjunct, single adjunct and 2 adjuncts.
 
at the end of 24 hours after completion of surgery 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 1 
Date of First Enrollment (India)   15/01/2025 
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 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   Postoperative pain after orthopedic lower limb surgery is a very distressing symptom and a major component of the postoperative morbidity.Considering the extensive number of orthopaedic surgeries undertaken every day and finding an opioid sparing and convenient options for analgesia, this study aims to investigate whether the adjuvant combination of dexamethasone and dexmedetomidine could additively provide a longer duration of blockade and superior analgesia compared to using Ropivacaine alone in a peripheral sciatic nerve block performed by the popliteal approach.

An ultrasound machine with a high frequency 9-13 MHz linear probe will be used considering the minimal penetration of tissues required. A 22G, 100 mm needle will be used to administer the block. Although approachable by the patient in the supine, lateral, or prone position, in order to minimize patient discomfort, especially when awake, patient is placed in the supine position with the legs elevated with folded blankets or an adjustable table. The skin is prepared with 0.5% chlorhexidine. The transducer is positioned in a transverse orientation at the popliteal fossa. At this level, the popliteal artery is identified and confirmed with colour flow or power doppler. Once the artery is visualized, the hyperechoic nerves are located superficially. To visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally, with the CPN travelling laterally and the TN staying medially, it is traced proximally. The optimal image is the configuration of the nerves just as they begin to separate, giving a peanut or figure 8 shape.

. HR, NIBP, SpO2 at 30 mins, 1hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours postoperatively

ii. Postoperative pain at rest and on movement as assessed by Numeric Rating Scale at 30mins, 1hour, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively

iii. Time to first rescue analgesic is noted in the post operative room as time of administration of morphine via epidural or Intravenous tramadol in case of SAB

 
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