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CTRI Number  CTRI/2024/11/077417 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Superior Hypogastric Plexus chemical ablation for Chronic pelvic pain in pelvic cancers 
Scientific Title of Study   Effectiveness of Superior Hypogastric Plexus Neurolysis for Chronic pelvic pain in pelvic malignancies - A 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 PRITHIKSHA S 
Designation  JUNIOR RESIDENT 
Affiliation  JIPMER 
Address  Department of Anaesthesiology And Critical Care office,Second floor,Institute block,Gorimedu PONDICHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  9952438737  
Fax    
Email  prithikshadr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr LENIN BABU E 
Designation  PROFESSOR & HEAD 
Affiliation  JIPMER 
Address  Department of Anaesthesiology And Critical Care office,Second floor,Institute block,Gorimedu PONDICHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  9487981140  
Fax    
Email  dr.lenin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr PRITHIKSHA S 
Designation  JUNIOR RESIDENT 
Affiliation  JIPMER 
Address  Department of Anaesthesiology And Critical Care office,Second floor,Institute block,Gorimedu PONDICHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  9952438737  
Fax    
Email  prithikshadr@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  JIPMER Campus Road, Gorimedu, Dhanvantari Nagar,Puducherry-605006 
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prithiksha  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Anaesthesiology and Critical Care office, Second floor, Institute Block, Gorimedu
Pondicherry
PONDICHERRY 		 9952438737

prithikshadr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER_INSTITUTIONAL_ETHICS_COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Oral Morphine for chronic pelvic pain with pelvic malignancies on pain and quality of life  Patients with chronic pelvic pain with pelvic malignancies will be started on Oral Morphine 5 mg 4th hourly. The dose of morphine will be stepped up based on VAS score. If VAS score is more than 7, the dose of Morphine will be stepped up at increments of 10 mg doses in divided doses till VAS score is less than 4. VAS score and Quality of life will be measured weekly once in first month, biweekly once in second month and once in the third month. 
Intervention  Superior Hypogastric Plexus neurolysis on chronic pelvic pain in pelvic malignancy on pain and quality of life   The patient will be positioned prone. Under sterile precautions, under fluoroscopic guidance, under local infiltration, Superior hypogastric plexus neurolysis will be done at Lumbo-sacral level (L5-S1) using posterior approach and location will be confirmed by radio-contrast material under intermittent fluoroscopic imaging. 0.125% of Bupivacaine will be injected followed by 8 ml of 97% of Alcohol on either side. Vitals will be monitored every 1 minute for 5 minutes, and 5 minutes for 30 minutes throughout the procedure. Adverse effects like numbness in the foot, difficulty in walking, hemodynamic instability will be looked for. VAS score and Quality of life will be measured immediately after intervention, at 24 hours, weekly once in first month, biweekly once in second month and once in the third month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with Chronic pelvic pain due to any type of pelvic malignancies
2. Patients with no symptomatic relief taking Tab 50 mg of Morphine(10 mg Q4H)
 
 
ExclusionCriteria 
Details  1.Spinal cord deformities
2.History of spine surgery
3.Increased vascularity along needle pathway from CT scan
4.History of allergy to local anesthetics
5.Not able to lie in prone position
6.Bleeding disorders
7.Psychiatric disorders
8.Pregnancy/Lactation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients with pelvic malignancies receiving block and Conventional oral Analgesia are compared on pain relief based on VAS Score from 0-10 cm  All patients will be evaluated for the reduction in the VAS score weekly for first month,then biweekly for the 2nd month then once in the last month through telephonic follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Patients with pelvic malignancies receiving block and Conventional oral Analgesia are compared based on
1.European Pain Federation Score(Quality of life)
2.Adverse effects
 		 European pain Federation Score,Adverse effects will be evaluated weekly for the first month,biweekly for the 2nd month then once in last month through telephonic communication. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   09/12/2024 
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="2"
Months="0"
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   After obtaining approval from the Post-graduate Research Monitoring committee (human studies), Institute Ethics committee (IEC) and completing Clinical trial registry India (CTRI) the study will commence. Patients with chronic pelvic pain  i.e.  pelvic malignancies with pain not being controlled on Oral Morphine Q4H , attending the Pain and Palliative Clinic after being referred from the Department of Regional Cancer Centre in JIPMER will be screened for eligibility to participate in the study. The patient will be explained regarding the procedure in detail.Those patients satisfying the inclusion criteria and are willing to participate in the study will be recruited after obtaining informed written consent. Before any intervention, the patients will undergo a detailed survey at the baseline which includes  CBC,RFT,LFT. The patients will be randomly allocated into any of the 2 groups based on a computer-generated block random number table and allocation into the groups will be concealedby the Serially Numbered Opaque Sealed Envelopes (SNOSE) technique. Two groups studied in this trial include Group I(receives Oral Morphine) Group II (receives Neurolytic Superior Hypogastric Plexus Block).8 hrs NPO status explained to patient the previous day of block,In the pain ward NPO ,premedications confirmed,18 G IV cannula secured and patient will be shifted to Operation theatre.In the operation theatre, the patient will be positioned prone on the table with a pillow between the lower abdomen and iliac crest to reduce lumbar lordosis. All ASA (American Society of Anesthesiologists) standard monitors will be attached which includes pulse oximetry, non-invasive blood pressure and electrocardiogram. Under sterile precautions, parts will be cleaned and draped. The level and the side to be blocked will be marked and confirmed again. Level identification will be done using sequential C-Arm images. At the appropriate lumbar-sacral spine level (L5-S1), local infiltration with 2%lignocaine will be given ,The tip of a 22-Gauge Chiba needle will be gradually advanced towards the anterior aspect of L5 under radiologic guidance. During the procedure, the lateral view will be obtained, and the needle will advance in the anterior direction. Optimal needle placement for injection in the location is confirmed by injecting a small volume of radio contrast media under intermittent fluoroscopic imaging. The contrast material (Iohexol Contrapaque®350, 350mg/ml) 1ml will be injected at that side to confirm that the needle is not intrathecal or intravascular,if the needle is intravascular the dye disappears ,whereas if the dye is intrathecal then there is a vertical spread of dye seen in the imaging.After ruling out the intrathecal and intravascular location of needle ,Drug with a volume of 2ml(Bupi 0.125%) will be injected in one side ,followed by the other side after confirming the location in other side followed by 8 ml 97% of Alcohol on each side. Vitals will be monitored every 1 minute for 5 minutes on the operating table after taking the patient to a supine position. Then the patient will be shifted to the pain clinic ward and all ASA standard monitoring will be done every 5 minutes for 30 minutes and then every hour for 3-4 hours. After assuring no side effects like numbness in the foot, difficulty in walking, no hemodynamic instability,the patient will be discharged home on the same day from the pain ward. In case of prolonged recovery, the patient will be transferred to the RCC ward for 1-day of observation. For both groups, following initial interventions, the patients will be advised to note down their analgesic score intheir pain diary. All patients will be evaluated for the reduction in the VAS score weekly for first month,then biweekly for the 2nd month then once in the last month through telephonic follow-up.European pain Federation Score,Adverse effects will be evaluated weekly for the first month,biweekly for the 2nd month then once in last month through telephonic communication. 

All patients’ will  be given Morphine 10 mg SOS on top of the analgesic treatment they are receiving and the analgesic requirements in both the groups will be noted.The Group I on Oral Morphine receiving 10mgQ4hrly,When patient’s pain is not relieved by this dosage,the dose of Morphine will be increased to15mgQ4hrly.

 
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