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CTRI Number  CTRI/2024/05/067936 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 26/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of the analgesia obtained by radiofrequency ablation versus chemical neurolysis (phenol) of splanchnic nerve in the management of upper abdominal chronic pain. 
Scientific Title of Study   Comparison of radiofrequency ablation versus chemical neurolysis (phenol) of splanchnic nerve in the management of chronic upper abdominal pain : A Randomised control 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  Sridhar M 
Designation  Senior Resident (Acad) 
Affiliation  AIIMS Rishikesh 
Address  Department of anesthesia , Level 6 , AIIMS Campus , Virbhadra road , Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8197348627  
Fax    
Email  sridharmn819@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Talawar 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of anesthesia , Level 6 , AIIMS Rishikesh , Virbhadra Road

Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941  
Fax    
Email  praveenrt64@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Talawar 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of anesthesia , level 6 , AIIMS Rishikesh , Virbhadra road

Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941  
Fax    
Email  praveenrt64@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh , Virbhadra road , Rishikesh , Dehradhun , Pin Code - 249203 , India  
 
Primary Sponsor  
Name  Sridhar M 
Address  Department of Anesthesia , Level 6 , AIIMS Rishikesh , Virbhadra road , Rishikesh , Dehradhun , Pin Code - 249203 , India 
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 Sridhar M  AIIMS Rishikesh  Department of Anesthesia , Division Of Pain Medicine , Level 6 , AIIMS Rishikesh , Virbhadra road , Rishikesh , Dehradhun , Pin Code -249203 , India
Dehradun
UTTARANCHAL 		 8197348627

sridharmn819@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS RISHIKESH  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  Chemical neurolysis (phenol) of Splanchnic nerve  Applying the same procedural steps employed in the RF block, we will replicate the process at the T11 vertebra using a 20-gauge 10 cm Chiba needle. However, instead of thermocoagulation, we will go for bilateral chemical (phenol) neurolysis. The confirmation of needle position was achieved by observing the distribution of 0.5 ml of contrast dye in both anteroposterior (AP) and lateral views. A total volume of 12 ml of 6% was injected in two 6 ml doses, administered on each side of the T11 vertebra. To prevent track formation and tissue necrosis due to phenol spread, 1 ml of 0.9% normal saline will be injected during the withdrawal of the needle. 
Intervention  Radiofrequency ablation of Splanchnic nerve   Under fluroscopy guidance ,a metal forceps guide will be placed on participant’s body, strategically positioning it so that the forceps tip projected precisely onto the lateral edge of the T10 vertebral body, positioned just below the costovertebral angle. This will become the designated entry point through the skin, strategically located within a 4 cm range from the spinous processes. akin to setting the stage for the subsequent steps, ensuring accuracy in the procedure. Following the application of local 2% lidocaine at the puncture site, the RF cannula (20- gauge, sharp curved, 100 mm length, 10 mm active tip) will carefully introduced and progressed with focused precision, utilizing an oblique view for a direct look at the needle;s end-on appearance. The cannula is advanced with meticulous attention, ensuring a gradual and precise approach. Confirmation of the final placement occurred by examining a posteroanterior (PA) image, where the cannula tip established contact with the lateral border of the vertebra, positioned below the costovertebral angle. Double checking the depth of the cannula through a lateral view before advancing it further. Maintaining close proximity to the periosteum, the cannula is carefully progressed until its active tip reached the border region between the anterior and middle third of the vertebral body. We will replicate the procedure at the T11 level, removing the stylets from the radiofrequency (RF) cannula. Following this, electrodes will be introduced into the cannula and linked to the RF generator. To guarantee the accurate positioning of both cannulas at distinct levels and rule out somatic nerve interference, sensory stimulation ensued. This involved a 50 Hz RF pulse of 2 ms width and voltage maintained below 1.5 V, expecting participants to report abdominal pain akin to their initial symptomatic pain or experience epigastric pressure. We will conduct motor stimulation using a 2 Hz RF pulse with a width of 2 ms and voltage kept below 3 V. It is emphasized that contractions of the intercostal muscles should be absent during stimulation; any observed contraction indicated that the active electrode tip was too proximal to the somatic intercostal nerve.The entire process was replicated on the opposite side.We will simultaneously generate four monopolar RF lesions at 85°C. Following a 90-second pause, an additional lesion was created after a 180-degree needle rotation, accompanied by repeated sensory and motor stimulation. Just before crafting each lesion, we will administered1 ml of dexamethasone (4 mg) and 2 ml of 2% lidocaine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)≥ 18 year of both sex who suffered from upper abdominal pain (visceral pain with VAS ≥4)for a duration of more than 3 months.
2)  Patients who were taking the maximum tolerable dose of opioids. 
3) 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   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in pain NRS score from baseline to 3 months post
intervention. 		 Baseline , 7 days , 1 month , 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Change in karnofsky performance status scale from baseline to 3 months post
intervention. 		 Baseline , 7 days , 1 month , 3 month 
Change in sleep score from baseline to 3 months post intervention.  Baseline , 7 days , 1 month , 3 month 
Change in Analgesic requirement (medication quantification scale) from baseline to 3
months post intervention. 		 Baseline , 7 days , 1 month , 3 month 
 
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)   10/06/2024 
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="6"
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   upper abdominal chronic pain can indeed be a burden , often indicative of various conditions . There are various modes of treatment for chronic abdominal pain not responding to conservative management which include splanchnic nerve neurolysis , celiac plexus neurolysis , implantable intrathecal drug delivering devices and spinal cord stimulators .Disparities in access to pain management resources add another layers of complexity , emphasizing the need for interventions that are not only effective but also adaptable to diverse healthcare landscapes . Hence we decided to do this study . 
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