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CTRI Number  CTRI/2023/11/059666 [Registered on: 08/11/2023] Trial Registered Prospectively
Last Modified On: 07/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two intervention pain modalities for cancer pain. 
Scientific Title of Study   Randomised double-blind comparative clinical study to compare efficacy of thoracic splanchnic nerves radiofrequency ablation at T11 and alcohol chemical neurolysis in upper abdominal cancer pain. 
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 Rampal Singh 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Raipur, Chhattisgarh 
Address  Department of Anaesthesiology, 4th Floor, A Block OT Complex, All India Institute Of Medical Sciences, GE Road Raipur, Chhattisgarh 492099, India

Raipur
CHHATTISGARH
492099
India 
Phone  9457086753  
Fax    
Email  lautikasingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rampal Singh 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Raipur, Chhattisgarh 
Address  Department of Anaesthesiology, 4th Floor, A Block OT Complex, All India Institute Of Medical Sciences, GE Road Raipur, Chhattisgarh 492099, India

Raipur
CHHATTISGARH
492099
India 
Phone  9457086753  
Fax    
Email  lautikasingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rampal Singh 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Raipur, Chhattisgarh 
Address  Department of Anaesthesiology, 4th Floor, A Block OT Complex, All India Institute Of Medical Sciences, GE Road Raipur, Chhattisgarh 492099, India

Raipur
CHHATTISGARH
492099
India 
Phone  9457086753  
Fax    
Email  lautikasingh@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, 4th Floor A-Block, AIIMS Raipur, GE Road, Raipur 492009, Chhattisgarh, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raipur, Cggattisgarh 
Address  Department of Anaesthesiology, 4th Floor A Block, AIIMS Raipur, GE Road, Tatibandh, Raipur, Chhattisgarh (CG) 492099, India 
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 Rampal Singh  All India Institute of Medical Sciences Raipur  Department of Anaesthesiology, 4th Floor , A Block, All India Institute of Medical Sciences Raipur, GE Road, Raipur 492009 Chhattisgarh, India
Raipur
CHHATTISGARH 
9027335921

lautikasingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institute Ethics Committee. All India Institute of Medical Sciences. Raipur  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 of splanchnic nerves   Chemical neurolysis of splanchnic nerves at T11 level with absolute alcohol. Agent and sequence: 1)2mL of local anaesthetic each side.(2% Lignocaine + 0.25% Bupivacaine , 1:1) 2) Absolute alcohol 6 ml each side. 3) 2mg of Dexamethasone each side.  
Intervention  Radiofrequency ablation of splanchnic nerves   Radiofrequency ablation of splanchnic nerves at T11 level. Agent and sequence: 1)2mL of local anaesthetic each side.(2% Lignocaine + 0.25% Bupivacaine , 1:1) 2) Conventional Radiofrequency with 20G thermocouple, 2 lesions each side. (80 & 85 degrees for 2 min each) 3) 2mg of Dexamethasone each side.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Cancer of Pancreas, gallbladder, Liver, Stomach, Intestine up to splenic flexure of
colon, lower one third of oesophagus. (Upper GI Malignancy)
2. Cancer pain not responding to morphine and other opioids like buprenorphine,
fentanyl patch
3. Coagulation parameters within normal limits
4. Life expectancy more than 3 months 
 
ExclusionCriteria 
Details  1. Uncontrolled international normalized ratio (INR)
2. Systemic or local infection
3. Expected survival less than 3 months, an
4. Eastern Cooperative Oncology Group (ECOG) score less than 3
5. Presence of a medical or psychiatric illness that would preclude informed consent or
follow-up
6. Patient mentally retarded, not following verbal commands during radiofrequency
ablation when checking sensory and motor testing 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the pain relief after bilateral thoracic splanchnic nerve radiofrequency
ablation at T11 with chemical neurolysis with absolute alcohol at T11. 
to assess at 7,14,21,28 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of side effects such as diarrhoea, hypotension and reduction
in oral morphine consumption, improvement in quality of life between two
techniques. 
to assess at 7,14,21,28 days 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 3 
Date of First Enrollment (India)   15/11/2023 
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 Yet Recruiting 
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  
Pancreatic cancer is associated with severe pain, morbidity, mortality, and poor survival [1].
It ranks as the fourth or fifth most common cause of cancer mortality [2]. The incidence of
pancreatic cancer in India is 0.5–2.4 per 100,000 men and 0.2–1.8 per 100,000 women.
According to Indian Council for Medical Research (ICMR) estimate from 2010 to 2020 there
were 40402 pancreatic cancer patients in India based on National Cancer Registry
Programme [3]. It has been observed that in advance stage of pancreatic cancer pain doesn’t
respond to pharmacological treatment, analgesics, opioids, and adjuvant medication [4,5,6].
Along with pain and morbidity, quality of life is seriously affected in these patients, so in
advance cases where pain doesn’t respond to medical treatment, pain management must be
carried out with the help of minimally invasive percutaneous procedures and palliative care
should be an early part of the overall therapeutic plan [7-9].
The sympathetic innervation of the abdominal viscera originates in the anterolateral horn of
the spinal cord. Preganglionic fibres from T5 to T12 rather than synapsing with the
sympathetic chain, these preganglionic fibres pass through sympathetic chain and ultimately
synapse on the celiac ganglia. The greater (T5-T9), lesser (T10-T11), and least splanchnic
(T12) nerves provide the major preganglionic contribution to the celiac plexus and transmit
most nociceptive information from the viscera including distal oesophagus, stomach,
duodenum, small intestine, ascending and proximal transverse colon, adrenal glands,
pancreas, spleen, liver, and biliary system [10]. It has been shown that in patients with
chronic abdominal pain, interruption of the coeliac plexus or splanchnic nerves can offer
symptomatic relief by inhibiting pathways (nociceptive) from the abdominal viscera to the
brain [11].
Neurolysis implies the destruction of neurons by placing a needle close to the nerve and
either injecting neuro-destructive chemicals agent or producing damage with a physical
method such as cold (i.e., cryotherapy) or heat (i.e., radiofrequency ablation, RFA). Pain
arising from upper abdominal viscera, is managed by minimally invasive procedures when
not controlled by pharmacological treatment via coeliac plexus or splanchnic nerves, either
by chemical neurolysis or radiofrequency ablation of splanchnic nerves. The first report of
chemical neurolysis for the treatment of pain was made, in 1863, by Luton who administered
neurolytic agents into painful area. Neural blockade with neurolytic agents has been
documented for the treatment of pain for over a century [12].

Absolute alcohol (99%) is a nonselective neurolytic agent and it’s perineural administration
results in protein denaturation and neurolysis (Wallerian degeneration). Effect persists for a
long time and provide analgesia for at least 3-6 months of duration [13].
Radiofrequency ablation (RFA) is an electrosurgical technique utilizing high frequency
alternating current to heat tissues leading to thermal coagulation. When cells are heated above
45°C, cellular proteins denature, and cell membranes lose their integrity as their lipid
component melts [14]. During RFA, a high frequency alternating current (350–500 kHz)
flows from the un-insulated tip of an electrode into the tissue. Ionic agitation is produced in
the tissue around the electrode tip as the ions attempt to follow the direction of the alternating
current and it is this agitation which results in frictional heating in the tissue around the
electrode [14-17]. As chemical neurolysis leads to protein denaturation of neural tissues so
that inhibiting pain impulse. In the same way thermocoagulation of sensory nerves should
also stop carrying pain impulse to brain. Thermo coagulation is a process in which nerves are
heated up to 80 to 85 degrees centigrade by radiofrequency generator. Temperature rise is
due to sodium and potassium ion’s oscillatory movement present in tissue. Rise in
temperature causes thermocoagulation of protein in neural tissue that leads to inhibition of
pain impulse to brain.

There are few studies regarding comparison between radiofrequency ablation and chemical
neurolysis of thoracic splanchnic nerves indicating superiority of study in terms of pain relief
and better quality of patient life. So, we have decided to compare these two techniques in
patients suffering from upper abdominal pain due to cancer of upper abdominal organs like
lower one third part of oesophagus, stomach, small intestine, large intestine up to splenic
flexure of colon, pancreas, liver, gallbladder which are likely to affect normal anatomy of
celiac plexus.
 
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