| CTRI Number |
CTRI/2024/03/064211 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study for comparison of two drugs combination of 0.0625% Levobupivacaine with Fentanyl and 0.1% Ropivacaine with Fentanyl for pain relief after a surgery named CRS+HIPEC |
|
Scientific Title of Study
|
A comparison of efficacy of 0.0625% Levobupivacaine with Fentanyl and 0.1% Ropivacaine with Fentanyl for postoperative analgesia after CRS+HIPEC-A pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Bhatnagar |
| Designation |
Consultant and Head Surgical ICU |
| Affiliation |
Rajiv Gandhi Cancer Institute & Research Centre New Delhi |
| Address |
Department of Surgical I.C.U.
Rajiv Gandhi Cancer Institute and Research Center
New Delhi
North West
DELHI
110085
India |
| Phone |
9910950363 |
| Fax |
|
| Email |
drvishalbhatnagar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Bhatnagar |
| Designation |
Consultant and Head Surgical ICU |
| Affiliation |
Rajiv Gandhi Cancer Institute & Research Centre New Delhi |
| Address |
Department of Surgical I.C.U.
Rajiv Gandhi Cancer Institute and Research center
New Delhi
North West
DELHI
110085
India |
| Phone |
9910950363 |
| Fax |
|
| Email |
drvishalbhatnagar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Bhatnagar |
| Designation |
Consultant and Head Surgical ICU |
| Affiliation |
Rajiv Gandhi Cancer Institute & Research Centre New Delhi |
| Address |
Department of Surgical I.C.U.
Rajiv Gandhi Cancer Institute and Research center
New Delhi
North West
DELHI
110085
India |
| Phone |
9910950363 |
| Fax |
|
| Email |
drvishalbhatnagar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Center
New Delhi |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute and Research Center |
| Address |
Rajiv Gandhi cancer institute and Research center
Sector-5,Rohini,New Delhi,India 110085 |
| 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 Vishal Bhatnagar |
Rajiv Gandhi Cancer Institute and Research Center |
Department of Surgical I.C.U.
North West
DELHI |
9910950363
drvishalbhatnagar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: K65-K68||Diseases of peritoneum and retroperitoneum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural analgesia |
continuous epidural infusion of 0.0625% Levobupivacaine with fentanyl 2 mcg/ml @ 6ml/hour for postoperative analgesia in cytoreductive surgeries with HIPEC. Haemodyanamic parameter and requirement of rescue analgesia noted at different level. Side effect of opoid and pain assessment by pain scores at diffent time interval till epidural placement |
| Comparator Agent |
Epidural local anesthetic drug with epidural opioids infusion |
Post operative in extubated patients continuous epidural infusion of 0.1% Ropivacaine with fentanyl 2 mcg/ml @ 6ml/hour for postoperative analgesia in cytoreductive surgeries with HIPEC. To check the pain scores at different interval to know the efficacy of drugs. Also requirement of rescue analgesia doses. Haemodynamic parameters compares with other group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patient undergoing CRS with HIPEC for solid organ GI and Ovarian malignancy with peritoneal metastasis |
|
| ExclusionCriteria |
| Details |
Patient refusal or contraindication for epidural catheter. ASA physical status 3 and more. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare VAS pain score to assess postoperative analgesia between two study groups |
Every 6 hourly on postoperative day then every 12 hourly for next 3-4 days till epidural catheter is in situ |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue analgesia doses and total volume of drug used for epidural infusion |
Every 6 hourly on postoperative day then every 12 hourly for next 3-4 days till epidural catheter is in situ |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/03/2024 |
| 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="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 is the study to compare the analgesic effectiveness and hemodynamic changes of continuous epidural infusion of 0.0625% Levobupivacaine with Fentanyl and 0.1% Ropivacaine with Fentanyl for postoperative analgesia after CRS+HIPEC. In both groups drugs will be infused @ 6ml/hr. Rescue analgesia will be provided with intravenous Injection tramadol 50 mg SOS. |