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CTRI Number  CTRI/2025/07/090451 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A comparative study of epidural and local anaesthesia for inta-operative and post-operative pain management in patients undergoing transforaminal endoscopic discectomy. 
Scientific Title of Study   Comparison of pain scores with epidural and local anaesthesia in patients undergoing transforaminal endoscopic discectomy - A prospective randomised trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshita Tiwari 
Designation  Junior Resident 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  8305760007  
Fax    
Email  abhilashashalini0910@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof A K Paswan 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9794855871  
Fax    
Email  dranil1973@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Yadav 
Designation  Associate Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Orthopedics Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9560754591  
Fax    
Email  drsanjay.pgi@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 
 
Primary Sponsor  
Name  Dr Harshita Tiwari 
Address  Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 
Type of Sponsor  Other [Self] 
 
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 Harshita Tiwari   Sir Sunderlal Hospital   Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH 		 8305760007

abhilashashalini0910@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee BHU Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administration of epidural anaesthesia and local anaesthesia  Administration of epidural anaesthesia by 10ml of 0.2 percent Bupivacaine to one group of participants and local anaesthesia by 15ml of 1 percent Lignocaine to other group of participants 
Comparator Agent  Epidural anaesthesia  Epidural anaesthesia by 10ml of 0.2 percent Bupivacaine prior to procedure 
Comparator Agent  Local anaesthesia  Local anaesthesia by 15ml of 1 percent Lignocaine locally prior to procedure 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. ASA grade 1 and 2
2. Patients undergoing single level lumbar discectomy
3. Typical symptoms of nerve compression not relieved with conservative management and epidural steroid injections 
 
ExclusionCriteria 
Details  1. Patients with sepsis
2. Patients with local site infection
3. Patients with allergy to local anaesthetics
4. Patients with coagulation abnormalities
5. Mentally unstable patients
6. Patients with hemodynamic instability
7. Severe systemic disease
8. Spinal abnormality
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A prospective randomised clinical trial to compare the analgesic efficacy of epidural and local anaesthesia in patients undergoing transforaminal endoscopic discectomy.  Assessment done at pre procedure, during sheath placement phase, during inter vertebral disc removal phase, at the end of procedure and 1 week post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the requirement of opioids between groups.
2. To compare the complications between groups.
3. To compare the hemodynamic parameters between groups.
4. To compare the patient satisfaction score as per Likerts’ scale between groups.
5. To compare the disability by Hindi version of Oswestry Disability Index (Hi-ODI) between groups.
6. To compare the pre and post procedure CRP levels.
 		 Assessment done at pre procedure, during sheath placement phase, during inter vertebral disc removal phase, at the end of procedure and 1 week post operatively. 
 
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   Phase 4 
Date of First Enrollment (India)   17/07/2025 
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="7"
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  

This study is an open labelled prospective randomized trial comparing the analgesic efficacy of epidural anaesthesia with 10 ml of 0.2 percent Bupivacaine  and local anaesthesia with 15 ml of 1 percent Lignocaine in patients undergoing transforaminal endoscopic discectomy. The study will be carried out in the Pain Division of Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi. The primary outcome will measure the extent of pain. The intensity of the pain variable will be recorded using a visual analog scale (VAS), ranging from 0 (no pain) to 10 (maximum pain). Each patient will be asked to rate the perceived pain at pre procedure, during sheath placement, during inter vertebral disc removal, at the end of procedure and 1 week post operatively. The secondary outcomes will be to observe the number of doses of rescue analgesia (IV Fentanyl) needed , compare the complications , hemodynamic parameters, patient satisfaction score (as per Likerts scale) and disability (by Hi-ODI) between groups and to compare pre and post procedure CRP levels.

 
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