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CTRI Number  CTRI/2025/01/079751 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Other 
Public Title of Study   Comparative Evaluation of Cervical Epidural Adhesiolysis vs. Selective Nerve Root Block in Managing Chronic Pain in Cervical Post-Surgery Syndrome: A Pilot Study 
Scientific Title of Study   Comparative Evaluation of Cervical Epidural Adhesiolysis and Selective Nerve Root Block in Managing Chronic Pain of Cervical Post-Surgery Syndrome: An Exploratory Pilot Study. 
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 AJIT KUMAR 
Designation  Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesiology, AIIMS, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  9910789377  
Fax    
Email  ajitdr.ajit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR AJIT KUMAR 
Designation  Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesiology, AIIMS, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  9910789377  
Fax    
Email  ajitdr.ajit@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR AJIT KUMAR 
Designation  Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesiology, AIIMS, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  9910789377  
Fax    
Email  ajitdr.ajit@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Nil 
Address  AIIMS, Rishikesh 
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 Manasa Kantha  AIIMS Rishikesh  Department of Anesthesiology, 6th floor, IPD block, Dehradun, Uttaranchal.
Dehradun
UTTARANCHAL 		 8985425894

drmanasakantha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G30-G32||Other degenerative diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cervical epidural adhesiolysis  Patients will undergo cervical epidural adhesiolysis using a specialized catheter under fluoroscopic guidance. The procedure involves targeted mechanical and chemical disruption of epidural adhesions, followed by the injection of a steroid and local anesthetic mixture to reduce inflammation and pain. duration thirty minutes 
Comparator Agent  selective nerve root block  Patients will receive an ultrasound or fluoroscopy-guided selective nerve root block at the affected cervical nerve root. The procedure involves the precise injection of a corticosteroid and local anesthetic mixture to alleviate nerve root inflammation and pain. duration thirty minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Had cervical surgery performed at least one year before enrollment. (cervical pain either persisting despite surgical intervention or appearing after surgical intervention) Had a history of chronic, function-limiting neck and upper extremity pain
lasting for at least 6 months following surgery. Pain unresponsive to conservative treatment including medical management,
physical therapy, and previous interventions.
Average pain score of more than 4 on an 11 point NRS. competent to understand the study protocol. Will be willing to provide
voluntary, written informed consent and willing to participate in the
assessment of outcome measurements. 
 
ExclusionCriteria 
Details  Patient refusal Pain for less than 6 months Coagulopathy and/or patients on anticoagulants. Infection at the site of injection. Hypersensitivity to local anesthetic agent. Evidence of severe psychiatric illness. Absence of prior cervical spine surgery. Uncontrolled or unstable opioid use Any conditions that might compromise the interpretation of outcome assessments. Pregnancy or lactation. History of any major comorbid medical conditions, those interfere with recording of study outcomes (neurological disorders, auto-immune diseases), multiple sclerosis, and pregnancy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain relief as assessed by Numerical Rating Scale (NRS) on a scale of 1-10
 		 at baseline and 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in functional status as measured by Neck disability index at
respective time intervals.  		 baseline, one month & three months 
Analgesic usage
Procedural complications (if any) 		 baseline 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   23/02/2025 
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="1"
Months="0"
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 pilot study compares the effectiveness and safety of cervical epidural adhesiolysis and selective nerve root block in managing chronic pain in cervical post-surgery syndrome. Primary outcomes include pain relief, functional improvement, and safety, aiming to guide treatment optimization for Cervical post surgery syndrome. 
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