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CTRI Number  CTRI/2024/09/074384 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 11/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Radiofrequency ablation of thoracic splanchnic nerves]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two methods of nerve treatment for managing cancer pain in the upper abdomen. 
Scientific Title of Study   Comparison of cooled versus conventional radiofrequency ablation of thoracic splanchnic nerves for the management of cancer pain: A prospective exploratory randomized controlled 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  Karthik Pandian 
Designation  Senior Resident in Pain Medicine 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Opd No: 16, Pain clinic, Department of Anesthesiology and Pain Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8056948411  
Fax    
Email  karthikmuthu970@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ajit Kumar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Opd No: 16, Pain clinic, Department of Anesthesiology and Pain Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9910789377  
Fax    
Email  ajitdr.ajit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karthik Pandian 
Designation  Senior Resident in Pain Medicine 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Opd No: 16, Pain clinic, Department of Anesthesiology and Pain Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8056948411  
Fax    
Email  karthikmuthu970@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249 203, India 
 
Primary Sponsor  
Name  Karthik Pandian M 
Address  Opd no:16, Pain clinic, Department of Anesthesiology and Pain Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249 203, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
All India Institute of Medical Sciences Rishikesh  All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249 203, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karthik Pandian M  All India Institute of Medical Sciences Rishikesh  Division of Pain Medicine, Department of Anesthesiology, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL 		 8056948411

karthikmuthu970@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (2) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (3) ICD-10 Condition: C188||Malignant neoplasm of overlappingsites of colon, (4) ICD-10 Condition: C229||Malignant neoplasm of liver, not specified as primary or secondary, (5) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (6) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (7) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, (8) ICD-10 Condition: C659||Malignant neoplasm of unspecifiedrenal pelvis, (9) ICD-10 Condition: C249||Malignant neoplasm of biliary tract, unspecified, (10) ICD-10 Condition: C749||Malignant neoplasm of unspecifiedpart of adrenal gland,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional radiofrequency ablation  Conventional radiofrequency ablation of bilateral thoracic splanchnic nerves at the T10 and T11 levels using a 10 mm active tip radiofrequency probe, administered at a temperature of 85°C at the probe tip for 90 seconds per nerve. The procedure is performed under image guidance to ensure accurate placement. The route of administration is through percutaneous needle insertion, and the total duration of the intervention is 90 seconds per nerve ablated. 
Intervention  Cooled radiofrequency ablation  Cooled radiofrequency ablation of bilateral thoracic splanchnic nerves at the T10 and T11 levels using a 4 mm active tip radiofrequency probe, administered at a temperature of 60°C at the probe tip for 150 seconds per nerve. The procedure is performed under image guidance to ensure accurate placement. The route of administration is through percutaneous needle insertion, and the total duration of the intervention is 150 seconds per nerve ablated.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Age: 18-70 years.
2) Patients of both sexes who have experienced upper abdominal pain (visceral pain with NRS greater than 4) for a duration of more than 3 months.
3) Patients who were taking the maximum tolerable dose of opioids. 
4) Splanchnic nerve accessible for bilateral neurolysis. 
 
ExclusionCriteria 
Details  1. Patient refusal,
2. Organ failure,
3. Coagulation disorders,
4. Local infection at the puncture site,
5. Sepsis,
6. Allergy to the contrast dye,
7. Pregnant women,
8. Psychiatric illness that affects cooperation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in pain NRS(numeric rating scale) score at rest   Baseline, 1 week, 1 month, and 3 months post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Change in sleep score (PSQI-The Pittsburgh Sleep Quality Index)  Baseline, 1 week, 1 month, and 3 months post-intervention 
Change in analgesic requirement (medication quantification scale)  Baseline to 3 months post-intervention 
To assess the complications of the intervention  3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) 30/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This prospective randomised controlled study seeks to address this gap in the literature by comparing the outcomes of cooled RFA and conventional RFA for the management of chronic abdominal cancer pain for 18 months in 60 patients at All India Institute of Medical Sciences Rishikesh. The aim is to compare and evaluate the analgesia obtained by cooled versus conventional radiofrequency ablation of the splanchnic nerve in the management of upper abdominal cancer pain.The primary objective is to evaluate the change in pain scores following the procedure. Secondary outcomes include change in sleep score, change in analgesic requirement, and procedure-related complications.

 
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