| CTRI Number |
CTRI/2018/05/013667 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
During surgery, blockade of celiac plexus for pain relief in patients having inoperable pancreatic or gastric or gall bladder cancer. |
|
Scientific Title of Study
|
Intraoperative celiac plexus neurolysis for pain relief in unresectable pancreatic, gastric and gall bladder cancer-A prospective randomized pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinod Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 139 First Floor
Dr BRA IRCH AIIMS Ansari Nagar
South
DELHI
110029
India |
| Phone |
01125795106 |
| Fax |
|
| Email |
vkchanpadia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 139 First Floor
Dr BRA IRCH AIIMS Ansari Nagar
South
DELHI
110029
India |
| Phone |
01125795106 |
| Fax |
|
| Email |
vkchanpadia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinod Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 139 First Floor
Dr BRA IRCH AIIMS Ansari Nagar
South
DELHI
110029
India |
| Phone |
01125795106 |
| Fax |
|
| Email |
vkchanpadia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BR Ambedkar Institute Rotary Cancer Hospital
AIIMS Ansari Nagar Delhi Pin code- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS |
| Address |
AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vinod Kumar |
All India Institute of Medical Sciences AIIMS |
Ansari Nagar East
South
DELHI |
01125795106
vkchanpadia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Healthy patient fit to undergo surgery, (1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group C |
20 ml Inj Ethanol (50%) with 5 ml 0.25% bupivacaine and 40 mg Triamcinolone will be injected bilaterally around celiac axis. |
| Comparator Agent |
Group D |
Pharmacological management of pain will be done according to WHO analgesic ladder i.e.
Step1-Non-opioids±Adjuvants
Step2-Weaker opioid for mild to moderate pain ± Non-opioid ± Adjuvants
Step 3-Stronger opioid for moderate to severe pain ± Non-opioid ± Adjuvants
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
40 patients of American Society of Anesthesiologist (ASA) physical status I, II and III of age group >18 years of either sex admitted at Dr BRA IRCH AIIMS and scheduled to undergo curative surgeries for pancreatic, stomach and gall bladder carcinoma but found unresectable at the time of laparotomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Respiratory insufficiency
3. Haemodynamic instability
4. Abnormal thyroid function
5. Renal or hepatic insufficiency,
6. History of any chronic pain
7. Unstable personality and abuse liability.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of intraoperative celiac plexus neurolysis with pharmacological therapy for management of postoperative pain on day 1, 2 and 3 in patients with unresectable pancreatic, stomach and gall bladder cancer. |
Postoperative day 1,2 and 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cumulative morphine consumption
Severity of pain and quality of life |
At 1,3 and 6 months of neurolytic procedure. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
10/05/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial will be conducted in patients having pancreatic, stomach and gall bladder cancer who will be planned for curative resection but found inoperable during surgery. Since these patients have poor prognosis and also complains of severe abdominal pain affecting quality of life. So, intraoperative celiac plexus neurolysis will be done and its analgesic efficacy will be compared with pharmacological therapy for management of postoperative pain on day 1, 2 and 3 in these patients. This study will also compare cumulative morphine consumption and assessment of severity of pain and quality of life in both groups at 1, 3 and 6 months after neurolytic procedure |