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CTRI Number  CTRI/2022/08/044592 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 02/08/2022
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 Compare post op pain relief in fracture femur surgeries with 3 in 1 block using levobupivacaine alone and tramadol and butorphanol as adjuvants 
Scientific Title of Study   Comparative Study Of Tramadol And Butorphanol As Adjuvants To Levobupivacaine In 3 In 1 Block For Post Operative Analgesia In Fracture Femur 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 Chiteshwar Walia 
Designation  Associate Professor 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research 
Address  Department of Anaesthesia SGRDIMSAR

Amritsar
PUNJAB
143001
India 
Phone  9878339933  
Fax    
Email  chiteshwarwalia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ruchi Gupta 
Designation  Professor and Head 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research 
Address  Department of Anaesthesia Sri Guru Ram Das Institute of Medical Sciences and Research

Amritsar
PUNJAB
143001
India 
Phone  9814320805  
Fax    
Email  drruchisgrd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankur Sharma 
Designation  Junior Resident 
Affiliation  SGRDIMSAR 
Address  Department of Anaesthesia SGRDIMSAR

Amritsar
PUNJAB
143001
India 
Phone  8837831283  
Fax    
Email  drzeus44@gmail.com  
 
Source of Monetary or Material Support  
Sri Guru Ram Dar Institute of Medical Sciences & Research, Amritsar 
 
Primary Sponsor  
Name  Sri Guru Ram Dar Institute of Medical Sciences Research 
Address  mehta Road, Vallah, Amritsar 
Type of Sponsor  Research institution and hospital 
 
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 Dar Institute of Medical Sciences & Research, Amritsar  Department of Anaesthesia, Sri Guru Ram Dar Institute of Medical Sciences & Research, Amritsar
Amritsar
PUNJAB 
9814320805

drruchisgrd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGRD ethical committe  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  Comparision of adjuvants given to 0.25% levobupivacaine  comparison of duration of post operative analgesia, ease of positioning for spinal anaesthesia, post operative requirement of diclofenac 75 mg intra-venous and paracetamol 15 mg/kg intravenous will be noted. Complications occuring in each case will be noted and compared. 
Intervention  Group I: 0.25% Levobupivacaine 20ml and Normal Saline(2mL)as adjuvant in femoral nerve block  Pre spinal anaesthesia, Femoral Nerve Block with above stated drug will be given. duration of post operative analgesia and ease of positioning for spinal anaesthesia will be noted. 
Intervention  Group II: 0.25% Levobupivacaine 20 ml & tramadol 1mg/kg as adjuvant in femoral nerve block  Pre spinal anaesthesia, Femoral Nerve Block with above stated drug will be given. duration of post operative analgesia and ease of positioning for spinal anaesthesia will be noted. 
Intervention  Group III: 0.25% levobupivacaine 20 mL and butorphanol 0. 06mg/kg as adjuvant in femoral nerve block   Pre spinal anaesthesia, Femoral Nerve Block with above stated drug will be given. duration of post operative analgesia and ease of positioning for spinal anaesthesia will be noted.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA Grade I-II undergoing femur fracture surgeries.  
 
ExclusionCriteria 
Details  1.A known history of allergy, sensitivity or any kind of reaction to the drugs
used in the study.
2.Contraindication to neuraxial blockade (less platelet count, significant neurological disease, diagnosed increased intracranial pressure, epidural lipomatosis, tumors fracture spine, caudaequina syndrome)
3.Bleeding disorders.
4.Large inguinal lymph nodes or tumor
5.Psychiatric patients/ Unco-operative patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using
• 0. 25% levobupivacaine and normal saline
• 0. 25% levobupivacaineand tramadol
• 0. 25% levobupivacaine and butorphanol
 
From the start of the Femoral nerve block to the 24 hrs after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using in terms of ease of positioning, duration of postop analgesia, requirement of rescue analgesia and adverse effects.  From the start of the Femoral nerve block to the 24 hrs after 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 2/ Phase 3 
Date of First Enrollment (India)   08/08/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Postoperative pain is often undertreated. Safe and effective pain management should be the primary goal to improve patient rehabilitation and satisfaction. Post operative pain relief can be achieved by a variety of techniques including parental NSAIDS (non-steroidal anti-inflammatory drugs), opioids, epidural analgesia, patient controlled analgesia and peripheral nerve blocks. Three in one femoral nerve block is relatively simple to perform, effective, low risk technique with a high success rate.

The 90 patients ASA grade I-II in age group 18-80 years undergoing fracture femur surgery at SGRD Amritsar will be studied with the aim of evaluating the effectiveness of addition of tramadol or butorphanol as adjuvants to levobupivacaine vs levobupivacaine and saline through 3 in 1 femoral nerve block randomly divided into 3 groups with 30 patients each receiving preemptive three in one nerve block either using 0.25% Levobupivacaine alone (Group I) or tramadol 1mg/kg (Group II) or butorphanol 0. 06mg/kg as adjuvant to 0.25% levobupivacaine (Group III). To every patient spinal anaesthesia using 0.5% heavy bupivacaine will be given. Ease of positioning, pain relief, and duration of post operative analgesia in all the three groups will be compared. In addition, post operative requirement of intravenous diclofenac 75 mg will be evaluated.

 
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