| 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
|
|
|
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
|
|
|
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 IntroductionUpper 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. |