| CTRI Number |
CTRI/2024/04/065876 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of surgeon versus anaesthetist delivered nerve block for pain relief in laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison of Surgeon Delivered Laparoscopic Transversus Abdominis Plane Blocks and Anaesthetist Delivered Ultrasound Guided Transversus Abdominis Plane Blocks in Laparoscopic colorectal surgeries- Randomised Control 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 |
INDUKRISHNA V |
| Designation |
DNB PG RESIDENT |
| Affiliation |
ASTER MEDCITY,KUTTISAHIB ROAD CHERANELLOOR,SOUTH CHITTOOR,KOCHI,KERALA |
| Address |
ASTER MEDCITY,
DEPARTMENT OF ANAESTHESIOLOGY,1ST FLOOR,ROOM NUMBER 1, ANAESTHESIA OFFICE
Ernakulam
KERALA
682027
India |
| Phone |
9447765770 |
| Fax |
|
| Email |
indukrishna.v.98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NISHA RAJMOHAN |
| Designation |
SENIOR CONSULTANT,DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
ASTER MEDCITY,KUTTISAHIB ROAD CHERANELLOOR,SOUTH CHITTOOR,KOCHI,KERALA |
| Address |
ASTER MEDCITY,
DEPARTMENT OF ANAESTHESIOLOGY,1ST FLOOR,ROOM NUMBER 1, ANAESTHESIA OFFICE
Ernakulam
KERALA
682027
India |
| Phone |
9656732203 |
| Fax |
|
| Email |
drnisha.rajmohan@asterhospital.com |
|
Details of Contact Person
Public Query
|
| Name |
NISHA RAJMOHAN |
| Designation |
SENIOR CONSULTANT,DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
ASTER MEDCITY,KUTTISAHIB ROAD CHERANELLOOR,SOUTH CHITTOOR,KOCHI,KERALA |
| Address |
ASTER MEDCITY,
DEPARTMENT OF ANAESTHESIOLOGY,1ST FLOOR,ROOM NUMBER 1, ANAESTHESIA OFFICE
Ernakulam
KERALA
682027
India |
| Phone |
9656732203 |
| Fax |
|
| Email |
drnisha.rajmohan@asterhospital.com |
|
|
Source of Monetary or Material Support
|
| ASTER MEDCITY,KUTTISAHIB ROAD CHERANELLOOR,SOUTH CHITTOOR,KOCHI,KERALA,PIN CODE:682027 |
|
|
Primary Sponsor
|
| Name |
INDUKRISHNA V |
| Address |
Primary sponsor is Aster Medcity,kuttisahib road Cheranelloor,South chittoor, Kochi, Kerala. |
| Type of Sponsor |
Other [SELF] |
|
|
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 INDUKRISHNA V |
ASTER MEDCITY |
DEPARTMENT OF ANAESTHESIOLOGY,1ST FLOOR,ROOM NUMBER 1, ANAESTHESIA OFFICE
Ernakulam
KERALA |
9447765770
indukrishna.v.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE ,ASTER MEDCITY,KOCHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anaesthetist delivered transversus abdominis plane block |
The intervention is such that the anaesthetist delivers transversus abdominis plane block under ultrasound guidance using 30ml of 0.25% bupivacaine with 0.1MG/KG dexamethasone as additive agent before the beginning of surgery in the transversus abdominis plane on both sides in around 5-10 minutes. |
| Comparator Agent |
Surgeon delivered laparoscopic transversus abdominis plane block |
The comparator agent is surgeon delivered laparoscopic transversus abdominis plane block under direct vision using 30ml of 0.25% bupivacaine with 0.1MG/KG dexamethasone as additive agent in the transversus abdominis plane on both sides in around 5-10 minutes after placing the laparoscope at the beginning of the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1,2 & 3
Laparoscopic colorectal surgeries
Consented for regional anaesthesia technique for post operative analgesia.
|
|
| ExclusionCriteria |
| Details |
ASA grade 4
Those who refuse to give consent.
Open colorectal surgeries.
Necessity of combined surgeries with colorectal surgery.
Local infections at proposed blocked site.
Contraindications to the use of loco regional anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is to compare surgeon placed Laparoscopic transversus abdominis plane blocks and anaesthetist placed ultrasound guided transversus abdominis plane blocks for post-operative pain control in laparoscopic colorectal surgery and to compare the primary duration of analgesia as determined by the vas score.
|
The time points are to measure vas score every hour for first 6hours, then at 12th hour and 24th hour post operatively and to measure vitals every 30 minutes till end of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome is to determine the incidence of post operative nausea & vomiting & to find out total dose of narcotics used(time frame –upto 24 hours) & also
to find out the time of rescue analgesia
|
Time points are every hour till first 6 hours, then at 12th hour & 24th hour post operatively. |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
30/04/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [indukrishna.v.98@gmail.com].
- For how long will this data be available start date provided 11-07-2026 and end date provided 27-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Enhanced recovery after surgery (ERAS) programs improve post-operative
outcomes and reduces cost in colorectal surgery.A multimodal, opiate sparing
pain regimen is a central component of ERAS protocols.Benefits of reducing
opiates include decreased post operative nausea,vomiting, and
sedation as well as reducing time to return of bowel function and expediting
patient recovery.The transversus abdominis plane (TAP) block is an important
non-narcotic adjunct for post-operative pain control in abdominal surgery.Surgeons
can use laparoscopic guidance for TAP block placement (LTAP), however, direct
comparisons to conventional ultrasound guided TAP (UTAPs) have been lacking. |