| CTRI Number |
CTRI/2026/03/106401 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [nerve block(splanchnic nerve)] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
pain relief after nerve block in upper abdominal cancer patients |
|
Scientific Title of Study
|
Patient related outcome measures (PROMs) following splanchnic nerve neurolysis in the management of upper abdominal cancer pain -A Prospective observational study |
| 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 Mounica K |
| Designation |
Postgraduate student |
| Affiliation |
Institute of anaesthesiology madurai medical college |
| Address |
No 121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical College,Madurai
TAMIL NADU 625020
India
Madurai
TAMIL NADU
625020
India |
| Phone |
7094416133 |
| Fax |
|
| Email |
mounicakathiresan2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil kumar MD DA |
| Designation |
Professor institute of Anaesthesiology Madurai medical college |
| Affiliation |
Institute of Anaesthesiology,madurai medical college |
| Address |
No 121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical College,Madurai
Tamil nadu
625020
India
Madurai
TAMIL NADU
625020
India |
| Phone |
9842188722 |
| Fax |
|
| Email |
drthendral29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil kumar MD DA |
| Designation |
Professor institute of Anaesthesiology Madurai medical college |
| Affiliation |
Institute of anaesthesiology madurai medical college |
| Address |
No 121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical College,Madurai
Tamil nadu
625020
India
Madurai
TAMIL NADU
625020
India |
| Phone |
9842188722 |
| Fax |
|
| Email |
drthendral29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mounica K |
| Address |
1587,Bharathi nagar,kattiyavayal,rajagopalapuram(post),pudukkottai 622003
tamil nadu
india
TAMIL NADU
INDIA |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mounica K |
Government Rajaji hospital and Madurai medical college |
Jica OT complex,4th floor,Pain clinic OT,Madurai,Tamil nadu
Madurai
TAMIL NADU |
7094416133
mounicakathiresan2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,government rajaji hospital and madurai medical college,madurai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Splanchnic nerve block in upper abdominal cancer patients |
To study the efficacy and pain releif after splanchnic nerve block in upper abdominal cancer patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years with intractable abdominal pain secondary to intra-abdominal malignancies
2.expected life expectancy more than 2 months
3.ability to give informed written consent
4.comply to follow up |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 yrs
2.surgically performed chemical splanchnicectomy
3.coagulopathy
4.local infection
5.known allergy to materials used |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the analgesic efficacy of Neurolytic Splanchnic Nerve Block in patients with intractable upper abdominal pain secondary to intra-abdominal malignancies. |
1 hour 24 hours 1 week 2 weeks 4 weeks 8 weeks 12 weeks 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of NSNB on quality of life.To determine the reduction in daily opioid consumption following the procedure.To evaluate the procedural safety — incidence of complications and adverse effects.To analyse patient survival outcomes following splanchnic nerve neurolysis |
1 hour 24 hours 1 week 2 weeks 4 weeks 8 weeks 12 weeks 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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 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
|
This review describes fluoroscopy-guided splanchnic nerve block for managing severe abdominal cancer pain. It explains the anatomy, technique, and use of diagnostic blocks, neurolysis, and radiofrequency ablation. The procedure provides significant pain relief, reduces opioid use, and improves quality of life in refractory cases. |