| CTRI Number |
CTRI/2024/03/064513 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| 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
|
Comparison of Pain control method with two techniques, Intravenous patient Control Analgesia with drug Morphine (IVPCA morphine)and epidural infusion with drug Levobupivacaine with fentanyl after a surgery named Robotic assisted minimal invasive esophagectomy for Carcinoma Esophagus |
|
Scientific Title of Study
|
Pain management after Robot-Assisted minimally invasive esophagectomy,comparison of analgesic efficacy of IV PCA morphine and epidural Levobupivacaine with fentanyl |
| 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 I.C.U. |
| Affiliation |
Rajiv Gandhi Cancer Institute & Research Center,Rohini, New Delhi |
| Address |
Department of Surgical I.C.U.
Rajiv Gandhi Cancer Institute & Research Center New Delhi
North West
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 I.C.U. |
| Affiliation |
Rajiv Gandhi Cancer Institute & Research Center New Delhi |
| Address |
Department of Surgical I.C.U.
Rajiv Gandhi Cancer Institute & Research Center New Delhi
North West
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 I.C.U. |
| Affiliation |
Rajiv Gandhi Cancer Institute & Research Center New Delhi |
| Address |
Department of Surgical I.C.U.
Rajiv Gandhi Cancer Institute & Research Center New Delhi
North West
Delhi
North West
DELHI
110085
India |
| Phone |
9910950363 |
| Fax |
|
| Email |
drvishalbhatnagar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Hospital & Research Center
Sector-5, Rohini,
New Delhi 110085 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute & Research Center Delhi |
| Address |
Rajiv Gandhi Cancer Institute & Research Center
Sector -5 Rohini Delhi 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 Hospital & Research Center |
Department of Surgical ICU
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: C159||Malignant neoplasm of esophagus, unspecified, (2) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (3) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural Local anaesthetic drug with epidural opoids infusion for post operative pain relief |
Continuous epidural infusion of 0.0625% Laevobupivacaine with fentanyl 2 mcg/ml @ 6 ml/hour for post op pain relief in robotic-assisted minimal invasive esophagectomy at 6 hr,12hr,24th hourly till 5th post operative day |
| Intervention |
intravenous patient control analgesia with morphine |
patient not having epidural catheter placed in OT and intravenous patient control analgesia with morphine used. Each dose of 0.5mg/1 ml of dose on remote button push at 6 hr,12hr,24th hourly till 5th post operative day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing Robotic esophagectomy
Patients willing to use IV Patient control Analgesia |
|
| ExclusionCriteria |
| Details |
Patient refusal for epidural catheter placement
ASA physical status 3 or 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 group |
Every 6 hourly on postoperative day then every 12 hourly for next 4 days till epidural catheter in situ or ivPCA morphine till 4th postop day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue analgesia doses and total volume of drug used for epidural infusion and in IVPCA group |
Every 6 hourly on postoperative day then every 12 hourly for next 4 days till epidural catheter in situ or ivPCA morphine till 4th postop day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
28/03/2024 |
| 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 2mcg/ml in one group and IVPCA morphine in other group fpr Postoperative analgesia In Robot-assisted minimally invasive esophagectomy. Rescue analgesia will be provided with intravenous injection 50 mg tramadol. |