| CTRI Number |
CTRI/2021/12/038974 [Registered on: 28/12/2021] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effect of Transversus abdominis plane block preoperatively versus postoperatively in patients undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
Comparative Study Of Pre-operative Ultrasound Guided Transversus Abdominis Plane block vs Post-operative Ultrasound Guided Transversus Abdominis Plane Block on Intraoperative Hemodynamic stability and Postoperative Analgesic Requirements in Patients undergoing Laparoscopic Abdominal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhanushree G |
| Designation |
Post Graduate Medical Student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and research Institute, KR Road, Bangalore
#106BMCRI ladies hostel opposite Tippu sultan summer palace K.R market Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
7975398842 |
| Fax |
|
| Email |
bhanuguddi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Rohit |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and research Institute, KR Road, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9611106641 |
| Fax |
|
| Email |
dr.soumyarohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Rohit |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and research Institute, KR Road, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9611106641 |
| Fax |
|
| Email |
dr.soumyarohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Victoria Hospital, Bowring and Lady curzon hospital and Vanivilas hospital affiliated to Bangalore medical college and research institute, K.R market Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Bhanushree G |
| Address |
Department of Anaesthesiology, Bangalore Medical College and research Institute, KR Road, Bangalore 560002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Soumya Rohit |
Department of Anaesthesiology, Bangalore Medical College and research Institute, KR Road, Bangalore 560002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhanushree G |
Bangalore medical college and Research Institute |
Department of Anaesthesiology, Bangalore Medical College and research Institute, KR Road, Bangalore 560002
Bangalore
KARNATAKA |
7975398842
bhanuguddi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI Ethics committee |
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 |
| Comparator Agent |
comparision between preoperative vs post-operative TAP block |
Group 1 will recieve TAP block before the start of surgery and Group 2 will revieve TAP block after the surgery |
| Intervention |
Injection Bupivacaine 0.25% |
Inj Bupivacaine 0.25% 20 mL injected on each side of abdominal wall at lumbar angle of petit in Transversus Abdominis plane
Group 1 receives block before the incision and Group 2 will receive block after the surgery before extubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving informed written consent
ASA class I and II
Patients posted for elective Laparoscopic abdominal surgeries
|
|
| ExclusionCriteria |
| Details |
patient who refused to give informed written consent
Emergency surgeries
Allergy for local anaesthetics and confirmed local anaesthesia toxicity |
|
|
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 |
| Peri-operative Hemodynamic status |
Baseline, 5min, 10min, during incision, during pneumoperitoneum, 15min, 30min, 1hr, 1hr 30 min, 2 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia and post-operative analgesic requirement |
post extubation, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour and 24 hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/01/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Transversus Abdominis Plane (TAP) block produces more
effective postoperative analgesia and significantly reduces consumption of
postoperative opioids after various abdominal surgeries. It can be performed
either preoperatively or postoperatively. Furthermore, studies investigating
the ideal period for TAP block administration are few.
The objective of our study was to investigate, which
period is more effective for administration of TAP block on perioperative
hemodynamic and postoperative analgesia in patients undergoing laparoscopic
abdominal surgeries. it will be conducted among patients undergoing elective laparoscopic surgeries will be divided into 2 groups of 40 each. After General anaesthesia 1 group will recieve TAP block before incision and other group 2 will recieve TAP block after surgery. Inj Bupivacaine 0.25% 20ml on each side of abdomen. perioperative hemodynamic status and post opreative analgesic requirement will be noted along with any adverse side effects |