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CTRI Number  CTRI/2020/12/029774 [Registered on: 14/12/2020] Trial Registered Prospectively
Last Modified On: 24/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study comparing two techniques-ultrasound versus fluoroscopic(x-ray guided) for a regional analgesia technique for chronic lower limb pain 
Scientific Title of Study   Ultrasound guided versus fluoroscopic guided lumbar sympathetic ganglion block:A prospective single blind randomized study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abini Shams 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Dr.Abini Shams Junior Resident Department of Anaesthesiology,Pain Medicine and Critical Care AIIMS New Delhi

South
DELHI
110029
India 
Phone  9656874911  
Fax    
Email  abinishams@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Virender Kumar Mohan 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Dr Virender Kumar Mohan Professor Department of Anaesthesiology,Pain Medicine and Critical Care AIIMS New Delhi

South
DELHI
110029
India 
Phone  9891557705  
Fax    
Email  dr_vkmohan@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Abini Shams 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Dr.Abini Shams Junior Resident Department of Anaesthesiology,Pain Medicine and Critical Care AIIMS New Delhi

South
DELHI
110029
India 
Phone  9656874911  
Fax    
Email  abinishams@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesNew Delhi 
Address  All India Institute of Medical Sciences Ansari Nagar East New Delhi 110029  
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 
Abini Shams  AIIMS New Delhi  Department of Anaesthesiology,Pain Medicine and Critical Care AIIMS Ansari Nagar East New Delhi 110029
South
DELHI 		 9656874911

abinishams@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute ethics committee,AIIMS New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I702||Atherosclerosis of native arteriesof the extremities, (2) ICD-10 Condition: I738||Other specified peripheral vascular diseases, (3) ICD-10 Condition: B022||Zoster with other nervous system involvement, (4) ICD-10 Condition: G905||Complex regional pain syndrome I (CRPS I), (5) ICD-10 Condition: G577||Causalgia of lower limb, (6) ICD-10 Condition: G546||Phantom limb syndrome with pain, (7) ICD-10 Condition: G893||Neoplasm related pain (acute) (chronic), (8) ICD-10 Condition: G620||Drug-induced polyneuropathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  fluoroscopic guided lumbar sympathetic ganglion block  Patient in lateral position,target vertebrae will be identified using C arm AP and oblique imaging.After insertion of needle final needle tip will be confirmed using fluoroscopy AP and lateral image. 
Intervention  Ultrasound guided lumbar sympathetic ganglion block  Patient in lateral position ,after visualising shamrock sonogram ,ultrasound guided in plane lumbar sympathetic ganglion block will be given at the level of L2 vertebra using 15ml 1% lignocaine+ 0.5% ropivacaine ,after confirming final needle tip position using AP and lateral fluoroscopy image  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Pain syndromes that requires lumbar sympathetic ganglion block(eg:pain with asymmetric skin temperature of lower limb,vascular insufficiency in lower limb extremities,post herpetic neuralgia,CRPS I and II,cancer related neuropathic pain,chemotherapy induced peripheral neuropathy,other lower extremity neuropathy).A score of 7 or more on the 11 point numerical rating pain scale 
 
ExclusionCriteria 
Details  A history of post lumbar laminectomy with internal fixation or any severe anatomic variation such as scoliosis and tumor.Any history of lumbar sympathetic chemical or thermal neurolysis.Pregnancy.Infection at puncture site.Coagulopathy.Allergy to local anaesthetics.Any cognitive dysfunction or inability to provide informed consent.BMI>35kg/m2 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Procedure time.Final needle tip position in ultrasound -guided and fluoroscopy guided technique.Spread of contrast  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Success rate  15 min after injection 
bone touching  Baseline 
procedure related complication  Baseline 
post procedure NRS  15min 
In room radiation exposure   15min 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   14/12/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   My study "ultrasound guided versus fluoroscopic guided lumbar sympathetic ganglion block :A prospective sinlge blinde randomized study.Fluoroscopic procdure is commonly used with success rate of 67% but disadvantage of radiation exposure.Ultrasound guided procedure not associated with radiation exposure and also have certain advantages.So we are doing this study for comparing this two techniques. 
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