Comparison of two intervention pain modalities for cancer pain.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/11/059666
- Lead Sponsor
- All India Institute of Medical Sciences, Raipur, Cggattisgarh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pain relief after bilateral thoracic splanchnic nerve radiofrequency to assess at 7,14,21,28 days ablation at T11 with chemical neurolysis with absolute alcohol at T11. to assess at 7,14,21,28 days
- Secondary Outcome Measures
Name Time Method To compare the incidence of side effects such as diarrhoea, hypotension and reduction in oral morphine consumption, improvement in quality of life between two
Trial Locations
- Locations (1)
All India Institute of Medical Sciences Raipur
🇮🇳Raipur, CHHATTISGARH, India
All India Institute of Medical Sciences Raipur🇮🇳Raipur, CHHATTISGARH, IndiaDr Rampal SinghPrincipal investigator9027335921lautikasingh@gmail.com