| CTRI Number |
CTRI/2023/04/051896 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound guided block versus standard care amongst robotic donor hepatectomy patients |
|
Scientific Title of Study
|
Comparison of postoperative analgesia with bilateral erector spinae plane block versus standard care in patients undergoing robotic donor hepatectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
17, Noel Heritage,Kizekkekara Road,
Trikakkara PO,
Ernakulam
KERALA
682021
India |
| Phone |
09496211333 |
| Fax |
|
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amaldev A |
| Designation |
Fellow, Hepatobiliary and solid organ transplant Anaesthesia |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
tower 6 Floor 1
Department of Anaesthesia
AIMS Kochi
Edapally
Kochi
682041
Ernakulam
KERALA
682041
India |
| Phone |
8281458782 |
| Fax |
912852020 |
| Email |
amaldev184@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amaldev A |
| Designation |
Fellow, Hepatobiliary and solid organ transplant Anaesthesia |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
tower 6 Floor 1
Department of Anaesthesia
AIMS Kochi
Edapally
Kochi
682041
Ernakulam
KERALA
682041
India |
| Phone |
8281458782 |
| Fax |
912852020 |
| Email |
amaldev184@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Tower 6 Floor 1
Edapally |
| 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 |
| Lakshmi Kumar |
Amrita Institute of Medical Sciences |
Tower 6 Floor 1
Department of Anaesthesia and critical Care
Ernakulam
KERALA |
9496211333
912852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Analgesia for hepatectomy |
Opioid infusions and multimodal analgesia intra and postoperatively as per protocol |
| Intervention |
Erector spinae block bilateral |
Bilateral ES catheters placed after anaesthesia and boluses of 0.2% ropivacaine given at timed intervals 8th hrly on either side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I ands II donors for right lobe robot assisted laparoscopic hepatectomy |
|
| ExclusionCriteria |
| Details |
Obesity BMI >35
Infections on the back
allergic reaction to drugs used for ES block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative analgesic requirement |
Postoperative 24 h after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Heart rate
2. Mean arterial Pressure
3. Pain assessed by NRS
4.Compliance to DVT prophylaxis
5. length of ICU stay |
1. Time of shifting T s
2. T 6: 6h in ICU
3. T 12: 12 H ICU
4. T 18 : 18 h ICU
5. T 24: 24 h ICU
6. Tic: Incentive spirometry
7. Ta: Ambulation
Intraoperative time points
T0: baseline
Tp: Port insertion
T p10: 10 mins of pneumoperitoneum
T Pf : Pfannelstiel incision
Tg : Graft retrieval
Tc :Closure
Te: End of surgery
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/05/2023 |
| 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
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We plan to assess the analgesic response of erector spinae catheters on post operative analgesic consumption amongst patients undergoing robotic donor hepatectomy. We belive that this will have an opioid sparing effect and may reduce the post operative ICU stay and improve analgesic quality amongst these patients |