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CTRI Number  CTRI/2021/01/030367 [Registered on: 11/01/2021] Trial Registered Prospectively
Last Modified On: 14/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Isobaric levobupivacaine with or without clonidine for spinal anaesthesia 
Scientific Title of Study   Evaluation of analgesic efficacy of clonidine as an additive to isobaric levobupivacaine in patients undergoing lower limb surgeries: A randomised controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR RS Rautela 
Designation  Director Professor 
Affiliation  University College of Medical Sciences, Delhi 
Address  531B Department of Anaesthesiology UCMS and GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  9625900699  
Fax    
Email  rsramb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RS Rautela 
Designation  Director Professor 
Affiliation  University College of Medical Sciences, Delhi 
Address  531B Department of Anaesthesiology UCMS and GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  9625900699  
Fax    
Email  rsramb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harsh Rathore 
Designation  PG student 
Affiliation  University college of Medical Science Delhi 
Address  Second Floor Main ICU Department of Anaesthesiology UCMS and GTBH Dilshad Garden Delhi

North
DELHI
110085
India 
Phone  9015739443  
Fax    
Email  hrathore15@gmail.com  
 
Source of Monetary or Material Support  
UNiversity College of Medical Sciences 
 
Primary Sponsor  
Name  Guru Teg Bahadur Hospital 
Address  Room No 531B Department of Anaesthesiology Dilshad Garden 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 RS Rautela  Guru Teg Bahadur Hospital  531B Department of Anaesthesiology GTB Hospital Delhi
North East
DELHI 		 9625900699

rsramb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituional Ethics Committee Human Research  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 
Comparator Agent  Subarachnoid block  15 mg of 0.5% isobaric levobupivacaine (3ml) + 15µg of clonidine (0.15ml) 
Comparator Agent  Subarachnoid block  15 mg of 0.5% isobaric levobupivacaine (3ml) + normal saline (0.15ml)  
Intervention  Subarachnoid block  SUbarachnoid block will be given and block characteristics will be compared 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA grade I or II
between 18-65 years
height 150-180 cm 
 
ExclusionCriteria 
Details  • Patients who do not give consent for subarachnoid block.
Patients with contraindication to subarachnoid block: infection at injection site, coagulopathy, space-occupying lesion, increased intracranial tension, known case of seizure disorder, pre-existing neurological deficit, and spine deformity.
History of allergy to any drug being used in the study.
Pregnant patients.
Known case of hepatic and renal disease, drug addicts and chronic alcoholics.
Patients who are on antiarrhythmic drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of effective analgesia   ONce
Time from the subarachnoid block to the time of patient’s first complaint of pain and VAS more than 3 
 
Secondary Outcome  
Outcome  TimePoints 
Sensory and motor block charactersitics  every 2 min for the first 10 min and then every 5 min till the same level is obtained in 3 consecutive readings 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/01/2021 
Date of Study Completion (India) 24/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Subarachnoid block will be given in sitting position under all aseptic precautions at the level of L2-L3 or L3-L4 intervertebral space as per the standard protocol. Intrathecal drug will be given according to the group allotted as under:

 

Group-LC: 15 mg of 0.5% isobaric levobupivacaine (3ml) + 15µg of clonidine (0.15ml)

 

Group-LS: 15 mg of 0.5% isobaric levobupivacaine (3ml) + normal saline (0.15ml)

 

The total volume of intrathecal drug will be 3.15 ml in both the groups.

Block characteristics will be assessed using loss of pinprick sensation for sensory block and Bromage Score for motor block. Hemodynamic variables will also be recorded.

Statistical analysis will be carried out in SPSS, software version 20.0 or latest. The quantitative parameters like age, height, weight, time of onset of block (when the sensory block is achieved at level of T10 dermatome), maximum height of sensory block achieved, duration of effective analgesia (time from giving subarachnoid block to patient’s first complaint of pain (VAS ≥ 3) and rescue analgesia given to patient which are recorded at onetime point will be compared using unpaired  t-test. Qualitative data like gender distribution, ASA physical status, quality of muscle relaxation, intensity of motor block and VAS score will be analysed using the Chi-square test or Fisher’s exact test whichever is applicable. Repeated measures ANOVA will be used to compare the hemodynamic variables. A p-value < 0.05 will be considered significant.


 
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