| CTRI Number |
CTRI/2025/03/082527 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
superior hypogastric plexus block via ultrasound guided versus fluoroscopy guided in patients with pelvic cancer |
|
Scientific Title of Study
|
Comparative evaluation of superior hypogastric plexus block via ultrasound guided versus fluoroscopy guided in patients with pelvic malignancies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revanth S |
| Designation |
Junior Resident |
| Affiliation |
Institute of medical sciences Banaras Hindu University Varanasi |
| Address |
Department of anesthesiology
Institute of medical sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9715551236 |
| Fax |
|
| Email |
revanthselvaraj96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha verma |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences,BHU |
| Address |
Department of anesthesiology
Institute of medical sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9559955988 |
| Fax |
|
| Email |
verma.nimisha5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha verma |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences,BHU |
| Address |
Department of anesthesiology
Institute of medical sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9559955988 |
| Fax |
|
| Email |
verma.nimisha5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology Institute of medical sciences, Banaras Hindu University, varanasi -221005 |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences, BHU |
| Address |
Institute of medical sciences, Banaras Hindu University, varanasi -221005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrRevanth S |
Institute of medical sciences Banaras Hindu University |
Pain operation theatre
second floor
Department of anesthesiology
Varanasi
UTTAR PRADESH |
9715551236
revanthselvaraj96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Superior hypogastric plexus block |
fluoroscopy guided superior hypogastric plexus block with 2-3 milliliters of 0.25% bupivacaine + 5ml of 70% alcohol
|
| Intervention |
Superior hypogastric plexus block |
USG guided superior hypogastric plexus block with 2-3 milliliters of 0.25% bupivacaine + 5ml of 70% alcohol |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with pelvic pain secondary to malignancy of either sex, in the age group of 30-65 years and American Society of Anaesthesiologists (ASA) grade II & III will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patient having chronic pelvic pain due to nonmalignant conditions
ASA Grade IV patients & Extra pelvic metastases
Patients with coagulopathy
Patients allergic to the study drugs.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare decrease in pain as assessed by change in visual analog scale score by ultrasound guided anterior approach versus fluoroscopy guided posterior approach of Superior Hypogastric Plexus neurolysis in patients with pelvic pain due to malignancies.
|
Preprocedure
Postprocedure - immediate,1 week,1 month,2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the feasibility of the procedures - time taken & patients comfort
To assess the complications associated with the two techniques
|
immediate,1 week,1 month,2 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
22/03/2025 |
| 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 Applicable |
| 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
|
Simple randomization using simple enumerated sampling method .After obtaining the institutional ethical committee approval and written informed consent from the participants, they will be enrolled into our study. A total of participants will be enrolled and randomized into two equal groups of each . i.e 28 in each group.
Group A : chronic pelvic pain patients receiving USG guided superior hypogastric plexus block with 2-3 milliliters of 0.25% bupivacaine + 5ml of 70% alcohol Group B : chronic pelvic pain patients receiving fluoroscopy guided superior hypogastric plexus block with 2-3 milliliters of 0.25% bupivacaine + 5ml of 70% alcohol The patients instructed prior to the scheduled procedure regarding how to evaluate pain by using visual analog pain scale (0=no pain, 10= maximum pain imaginable)
After which the following primary & secondary objectives will be assessed accordingly.
PRIMARY OBJECTIVE To compare decrease in pain as assessed by change in visual analog scale score by ultrasound guided anterior approach versus fluoroscopy guided posterior approach of Superior Hypogastric Plexus neurolysis in patients with pelvic pain due to malignancies.
SECONDARY OBJECTIVE To assess the feasibility of the procedures - time taken & patients comfort To assess the complications associated with the two techniques
|