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CTRI Number  CTRI/2024/11/077512 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 09/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Interventiona Analgesic Support ]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To study the enhanced effect of Dexmedetomidine in Splanchnic Plexus Neurolysis when complared to other combination of drugs : A Double-Blind Randomized Controlled Trial 
Scientific Title of Study   Enhancing Splanchnic Neurolysis With Dexmedetomidine: A Double-Blind Randomized Controlled 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  Dr Allwin J 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 155, Palliative Care Unit, Dr BRA IRCH, All India Institute of Medical Sciences New Delhi

South West
DELHI
110029
India 
Phone  7395993119  
Fax    
Email  jallwinj@gmaill.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurabh Vig  
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Dr Saurabh Vig Room 16, Academic Block National Cancer Institute, AIIMS Jhajjar

Jhajjar
HARYANA
124105
India 
Phone  9538247725  
Fax    
Email  saurabh377@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saurabh Vig  
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Dr Saurabh Vig Room 16, Academic Block National Cancer Institute, AIIMS Jhajjar


HARYANA
124105
India 
Phone  9538247725  
Fax    
Email  saurabh377@yahoo.com  
 
Source of Monetary or Material Support  
Department of Onco Anaesthesia and Palliative Medicine Dr BRA IRCH AIIMS, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Dr BRA IRCH All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurabh Vig  Dr. B.R.A Institute-Rotary Cancer Hospital  Room number 154, First floor, Palliative Care Unit, Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R.A Institute-Rotary Cancer Hospital All India Institute of Medical Sciences Ansari Nagar New Delhi
South West
DELHI 
9538247725

saurabh377@yahoo.com 
Dr Saurabh Vig  National Cancer Institute  Palliative Medicine Ward, 1A, Frist Floor, Hospital Block, National Cancer Institute AIIMS Jhajjar
Jhajjar
HARYANA 
9538247725

saurabh377@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee For Post Graduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C248||Malignant neoplasm of overlappingsites of biliary tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Splanchnic Neurolysis with 96% alcohol and 1% Lignocaine   96% alcohol and 1% Lignocaine injected in T11 level via C arm guidance perineurally. Frequency - STAT dose Duration - nil 
Comparator Agent  Splanchnic Neurolysis with 96% alcohol, 0.2% Lignocaine + Dexmedetomidine 2mcg/kg  96% alcohol and 0.2% Lignocaine + Dexmedetomidine 2mcg/kg injected in T11 level via C arm guidance perineurally. Frequency - STAT dose Duration - nil 
Intervention  Splanchnic Neurolysis with 96% alcohol, 1% Lignocaine + Dexmedetomidine 2mcg/kg  96% alcohol and 1% Lignocaine + Dexmedetomidine 2mcg/kg injected in T11 level via C arm guidance perineurally. Frequency - STAT dose Duration - nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult patients aged 18 years and above.
2. Diagnosis of upper gastrointestinal malignancy with abdominal pain (gastric, pancreatic, liver, or gallbladder cancers).
3. Ability to provide informed consent to participate in the study.
4. Willingness to comply with study procedures and follow-up visits.
5. Eastern Cooperative Oncology Group (ECOG) physical status classification I-III. 
 
ExclusionCriteria 
Details  1. Patients with contraindications to splanchnic neurolysis.
2. Known allergy or hypersensitivity to Lignocaine, Dexmedetomidine, or any other study medications.
3. History of severe cardiac disease, including significant arrhythmias, heart block, or severe heart failure.
4. Coagulopathy or bleeding disorders.
5. Inability to provide informed consent or comply with study procedures.
6. Infection at needle insertion site. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Peri-procedural pain score measured in VAS scale  During alcohol injection and 5 minutes post-injection 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the post-procedural VAS scores  1hr, 2hrs, 6hrs, 12hrs, 24hrs 
To compare the opioid consumption in the first 24 hours post-procedure among different groups.  24 hours 
To evaluate and compare the incidence of complications (during the procedure and first 24 hours post-procedure) such as hypotension, bradycardia, and burning pain from alcohol injection, across study groups.  24 hours 
To assess patient-reported satisfaction levels with pain control and overall procedural experience.  24 hours 
To compare pain scores and analgesic consumption at follow-up   1 week, 2 weeks, 1 month, 2 months 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/12/2024 
Date of Study Completion (India) 01/04/2026 
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)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Analysis and manuscript writing underway 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Enhancing Splanchnic Neurolysis with Dexmedetomidine: A Double-Blind Randomized Controlled Trial

Introduction

Upper gastrointestinal (GI) malignancies, including cancers of the oesophagus, stomach, pancreas, liver, and gallbladder, present a substantial burden globally [1], with a particularly higher prevalence in Asia. Chronic abdominal pain is a distressing symptom for individuals with upper GI cancer, significantly affecting their quality of life and potentially contributing to disease progression [5,6]. While pharmacotherapy, mainly opioids, is commonly employed for pain management, it has inherent limitations and potential side effects [10].

Interventional therapies such as sympathetic neurolytic blocks targeting the celiac plexus or the splanchnic plexus of nerves have shown effectiveness in alleviating pain associated with upper GI cancers [18-23]. These procedures involve the injection of local anaesthetic drugs or neurolytic agents to block pain signals. Studies have suggested comparable efficacy between celiac plexus neurolysis and splanchnic neurolysis.

Common neurolytic agents such as alcohol and phenol are used for chemical neurolysis but can induce severe pain during injection, and in the initial period after injection due to degradation of the underlying tissue and nerves. This periprocedural and immediate post-procedural burning pain may last up to 24 hours till the drug gives its full effect [52]. This burning pain may be very distressing for the patient. Generally, a local anaesthetic injection is given before the injection of a neurolytic agent to minimize this burning pain. Dexmedetomidine, an alpha-adrenergic agent, has emerged as a promising adjunct for pain management in neurolysis procedures, showing improvement in pain outcomes and reduced opioid consumption without significant side effects. Additionally, Dexmedetomidine may help alleviate the burning pain associated with alcohol injections.

A recent study [47] suggested that adding Dexmedetomidine to the chemical splanchnic neurolysis process reduced the burning pain due to tissue degradation and thus led to reduced morphine consumption. Nonetheless, this study had limitations, including a small sample size, variable drug dilutions of Lignocaine and Dexmedetomidine injected before alcohol injection and a brief follow-up period, highlighting the need for further investigation.

By elucidating the comparative effectiveness and safety profiles of Dexmedetomidine and Lignocaine as adjuncts to alcohol during chemical neurolysis, we aim to offer clinicians evidence-based insights into selecting the optimal approach for pain relief in alcohol neurolysis procedures. Improved pain control not only positively impacts patient satisfaction and quality of life but also enhances procedural outcomes.

 

 
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