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CTRI Number  CTRI/2024/11/077432 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Comparison of effect of two different drugs under a single injection for patients coming for below knee surgeries and monitor postoperative pain relief for next 24 hours 
Scientific Title of Study   Buprenorphine vs Clonidine as adjuvant for ultrasound guided popliteal sciatic nerve block in lower limb surgeries,A double blinded randomised study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinith kumar R 
Designation  Pg resident 
Affiliation  Chettinad academy of Research and Education Chettinad health city 
Address  Vinith Kumar Department Of Anaesthesiology Chettinad Academy of Research and Education D block 1st floor Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kancheepuram District Chennai

Kancheepuram
TAMIL NADU
603103
India 
Phone  9159223344  
Fax    
Email  Vinithkumar1827@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anand S 
Designation  Professor 
Affiliation  Chettinad Academy of Research and Education Chettinad Health City 
Address  Professor Of Department Of Anaesthesiology Chettinad Academy of Research and Education D block 1st floor Chettinad Health City Rajiv Gandhi Salai,Kelambakkam Kancheepuram District Chennai

Kancheepuram
TAMIL NADU
603103
India 
Phone  9444486183  
Fax    
Email  dr_muruganand@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vinith kumar  
Designation  Pg Resident  
Affiliation  Chettinad Academy of Research and Education Chettinad Health City 
Address  Department Of Anaesthesiology Chettinad academy of research and education Chettinad health city D block 1st floor Rajiv Gandhi salai ,Kelambakkam Kancheepuram District, Chennai


TAMIL NADU
603103
India 
Phone  9444486183  
Fax    
Email  Vinithkumar1827@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology Chettinad Academy of Research and Education D block 1st floor Chettinad Health City Rajiv Gandhi salai Kelambakkam Kancheepuram District Chennai 603103 Tamil Nadu India 
 
Primary Sponsor  
Name  Chettinad hospital and research institute  
Address  Chettinad Health City D Block 1st Floor Chettinad Academy OF Research And Education Chettinad Health City Rajiv Gandhi Salai Kelambakkam Kacheepuram District Kancheepuram Chennai Tamilnadu 
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 VIinith Kumar R  Chettinad academy of research and education   Department of Anaesthesiology D Block1st Floor Chettinad Academy of Research and Education Chettinad Health City Rajiv Gandhi Salam Kelambakkam Kancheepuram District Kancheepuram Tamilnadu
Kancheepuram
TAMIL NADU 		 9159223344

Vinithkumar1827@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CARE IHEC-I  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  Buprenorphine 0.5 mL with 2% lignocaine adrenaline 15ml and 5ml normal saline  Buprenorphine 0.5 mL with 2% lignocaine adrenaline 15 mL and normal saline 5ml in ultrasound guided popliteal block in patient scheduled for below knee surgeries and will be assessed post operatively for the next 24 hrs The frequency will be 1 time,The route of administration will be around the peripheral nerve The duration will be around 15 mins 
Comparator Agent  Clonidine 0.5 mL with 2% lignocaine adrenaline 15 mL and 5 mL normal saline  Clonidine 0.5 mL with 2% lignocaine adrenaline 15 mL and normal saline 5ml in ultrasound guided popliteal block in patient scheduled for below knee surgeries and will be assessed post operatively for the next 24 hrs The frequency will be 1 time,The route of administration will be around the peripheral nerve The duration will be around 15 mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients coming for below knee surgeries coming for both elective and emergency with American society of Anaesthesiologist(ASA) grade 1,grade 2,grade 3 
 
ExclusionCriteria 
Details  Patient refusal
Known allergy to local anesthetics
Bleeding diathesis
Use of any anti-coagulants
Inability to provide informed consent
Severe kidney or liver disease
Patient with psychiatric disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia  First 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the additional analgesic requirement in first 24 hours  First 24 hours 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 2 
Date of First Enrollment (India)   09/12/2024 
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   INTRODUCTION
  • The aim of the study was to compare the effectiveness of ultrasound-guided popliteal nerve block with two different additives with 2% xylocaine adrenaline in below knee surgeries,The popliteal nerve block is a block of the sciatic nerve in the popliteal fossa with the patient in the prone position,The block is ideal for surgeries of the lower leg, particularly the foot and ankle.



  • By using ultrasound,the local anesthetic must be deposited proximal to the splitting of the sciatic nerve. By placing the probe at the popliteal crease and scanning the leg in the cephalad direction,both the tibial and peroneal components of the sciatic nerve can be visualized separately as they coalesce to form the sciatic nerve

OBJECTIVES

Primary objective:

  • To determine the duration of effect of us guided popliteal sciatic nerve block with dose of 15 ml 2% lignocaine adrenaline with additive buprenorphine 0.5 ml with 5 ml normal saline and 15 ml of 2%lignocaine adrenaline with clonidine 0.5 ml and 5 ml normal saline to find out the onset and duration of anaesthesia

Secondary objective:

  • To determine the requirement of tramadol as rescue analgesia in the first 24 hours

Study design


 This study was designed as a Double blinded,Randomised control study 


SAMPLE SIZE

Total sample size=68

Group A=34

Group B =34


INCLUSION CRITERIA

  • Patient coming for below knee surgeries with ASA grade1, grade 2, grade 3
EXCLUSION CRITERIA
  • Patient refusal
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Patient with psychiatric disorders

METHODOLOGY

  • All patients will be premedicated with alprazolam 0.5 mg orally.Heart rate, noninvasive blood pressure, and peripheral O2 saturation will be continuously monitored during surgery and in the postoperative period
  • Place the patient in the lateral position with the operative leg supported below the knee.
  • Using high frequency ultrasound,a 23-G quincke needle will be introduced at least 7-cm superior to the popliteal crease 
  • With the probe parallel to the popliteal crease and at a level proximal to the nerve split, insert the needle at the lateral aspect of the probe and advance it toward the nerve. After the sciatic sheath is penetrated and the nerve is stimulated, inject 15mL of 2% xylocaine with adrenaline and buprenorphine 0.5ml in Group A and inject 15mL of 2% xylocaine with adrenaline and Clonidine 0.5ml 
REFERENCES

 1. López-González JM, López-Álvarez S, Jiménez Gómez BM, Areán González I, Illodo Miramontes G, Padín Barreiro L. Ultrasound-guided transversalis fascia plane block versus anterior transversus abdominis plane block in outpatient inguinal hernia repair. Rev Esp Anestesiol Reanim. 2016 Nov;63(9):498-504. English, Spanish. doi: 10.1016/j.redar.2016.02.005. Epub 2016 Apr 8. PMID: 27067036.

2. Rahimzadeh P, Faiz SH, Imani F, Jahromi MR. Comparison between ultrasound guided transversalis fascia plane and transversus abdominis plane block on postoperative pain in patients undergoing elective cesarean section: a randomized clinical trial. Iran Red Crescent Med J. 2018 Sep 1;20(9):7.

3. Kadam RV, Field J. Ultrasound-guided continuous transverse abdominis plane block for abdominal surgery. Journal of anaesthesiology, clinical pharmacology. 2011 Jul;27(3):333.


 
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