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CTRI Number  CTRI/2020/08/027214 [Registered on: 18/08/2020] Trial Registered Prospectively
Last Modified On: 14/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the postoperative pain in patients of lower limb surgeries  
Scientific Title of Study   To evaluate the postoperative analgesia of isobaric levobupivacaine alone compared with clonidine or nalbuphine under spinal anesthesia in patients of lower limb surgeries  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anita Kumari 
Designation  Professor 
Affiliation  SGRDIMSAR 
Address  Department of Anaesthesia, SGRDIMSAR, Amritsar
Anaesthesia deptt, Amritsar
Amritsar
PUNJAB
143501
India 
Phone  9815632909  
Fax    
Email  kumarianitadr1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Chawla 
Designation  Professor 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research 
Address  Department of Anaesthesia, SGRDIMSAR, Amritsar
Anaesthesia & Critical carev SGRDIMSAR, Amritsar
Amritsar
PUNJAB
143501
India 
Phone  9915530033  
Fax    
Email  sgrdanaesthesia.academics@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Balpreet Kaur 
Designation  Junior Resident 
Affiliation  SGRDIMSAR 
Address  SGRDIMSAR, Amritsar
Anaesthesia Deptt, SGRDIMSAR, Amritsar
Amritsar
PUNJAB
143501
India 
Phone  8283878948  
Fax    
Email  balpreetkaur55@gmail.com  
 
Source of Monetary or Material Support  
Sri Guru ram Das Institute of Medical Sciences and Research, Sri Amritsar 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [] 
 
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 Ruchi Gupta  Sri Guru Ram Das Institute of Medical Sciences & Research  Operation theatre Anaesthesia Department SGRDIMSAR, Amritsar
Amritsar
PUNJAB 		 9814320805

drruchisgrd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGRD ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine, nalbuphine with levobupivacaine  The study will consist of 90 patients randomly divided into three groups of 30 each- group A:0.5% Isobaric levobupivacaine 15mg + 400μg nalbuphine, group B: 0.5% lsobaric levobupivacaine 15mg + 30µg clonidine and group C: only isobaric levobupivacaine 0.5% intrathecally.  
Intervention  Intrathecal drugs  groups will be compared with respect to onset and duration of sensory and motor blockade,duration of postoperative analgesia, sedation score, side effects and complications. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients undergoing lower limb surgeries
2. American Society of Anesthesiology (ASA) Grade I and II
 
 
ExclusionCriteria 
Details  1.Neurological and musculoskeletal disease.
2.Patients with cardiovascular diseases.
3.Contraindications to regional anesthesia such as local infections/sepsis at the site of lumbar puncture, anatomical disorders of spine, shock, any bleeding disorder and patient on anticoagulants.
4.Hypersensitivity to study drugs
5.Pregnant women
6.History of opioid dependence
 
 
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 
To evaluate the duration of postoperative analgesia of isobaric levobupivacaine alone compared with clonidine or nalbuphine under spinal anesthesia in patients of lower limb surgeries.  pain will be assessed from 0 min till the 24 hours of the surgery  
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate the sedative and adverse effects of all the three drugs in the lower limb surgeries  effects will be assessed from 0 min till the 24 hours of the surgery  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/08/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hyperbaric bupivacaine 0.5% iscommonly used in spinal anesthesia. Hyperbaric solutions may cause sudden cardiac arrest due to hypotension, bradycardia because of higher extend of sympathetic blockade. The use of isobaric solutions may decrease these risks. Levobupivacaine is preferred during spinal anesthesia due to its lower cardiovascular side-effects and central nervous system toxicity. Intrathecal adjuvants are commonly used to improve the quality of intraoperative analgesia and extend it in the postoperative period without significant motor or autonomic blockade.

 
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