CTRI Number |
CTRI/2022/01/039194 [Registered on: 06/01/2022] Trial Registered Prospectively |
Last Modified On: |
05/01/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Biological Surgical/Anesthesia Preventive Screening |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
TO OBTAIN BEST MODE OF POST OPERATIVE ANALEGESIA FOR PATIENTS POSTED FOR LAPROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANESTHESIA |
Scientific Title of Study
|
EFFECTIVENESS OF PERI-OPERATIVE MULTI MODAL ANALGESIA WITH ULTRASOUND GUIDED BILATERAL SUBCOSTAL TAP BLOCK FOR POST OPERATIVE ANALGESIA IN ELECTIVE LAPROSCOPIC CHOLECYSTECTOMY PATIENTS UNDER GENERAL ANESTHESIA-A COMPARATIVE STUDY. |
Trial Acronym |
SEOMAFPMILC |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Deepika K C |
Designation |
Junior Resident |
Affiliation |
Vydehi Institute of medical sciences and research centre |
Address |
NO 180 9th Main 2nd Cross BCC layout Vijayanagar 2nd stage Bangalore
560040
Department Of Anesthesia
Vydehi Institute of medical sciences and research centre
bangalore
560066 Bangalore KARNATAKA 560040 India |
Phone |
9916546045 |
Fax |
|
Email |
deepukc25@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Radhika Dhanpal |
Designation |
Head of the Department of Anesthesia |
Affiliation |
Vydehi Institute of medical sciences and research centre |
Address |
Department Of Anesthesia
Vydehi Institute of medical sciences and research centre
bangalore
560066 Department Of Anesthesia
Vydehi Institute of medical sciences and research centre
bangalore
560066 Bangalore KARNATAKA 560066 India |
Phone |
9980506707 |
Fax |
|
Email |
radhika.dhanpal@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Deepika K C |
Designation |
Junior Resident |
Affiliation |
Vydehi Institute of medical sciences and research centre |
Address |
Department Of Anesthesia
Vydehi Institute of medical sciencesnd research centre
bangalore
560066 Department Of Anesthesia
Vydehi Institute of medical sciences and research centre
bangalore
560066 Bangalore KARNATAKA 560066 India |
Phone |
9916546045 |
Fax |
|
Email |
deepukc25@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
VIMS and RC |
Address |
Vydehi Institute of medical sciences |
Type of Sponsor |
Private medical college |
|
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 |
Deepika K C |
VIMS and RC |
Department of Anesthesia
VIMS and RC
bangalore
560066 Bangalore KARNATAKA |
9916546045
deepukc25@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Vydehi Institute of Ethics Commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
PRE-OP PREGABALIN 150 MG PO AN HOUR BEFORE SURGERY
INJ DEXA 8MG IV AT INDUCTION
ULTRASOUND GUIDED BILATERAL SUBCOSTAL TAP BLOCK WITH 20 ML OF 0.25% BUPIVACAINE |
PERI-OPERATIVE MULTI MODAL ANALGESIA WITH ULTRASOUND GUIDED BILATERAL SUBCOSTAL TAP BLOCK FOR POST OPERATIVE ANALGESIA IN ELECTIVE LAPROSCOPIC CHOLECYSTECTOMY PATIENTS |
Comparator Agent |
PRE-OP PREGABALIN 150 MG PO AN HOUR BEFORE SURGERY GROUP P
INJ DEXA 8MG IV AT INDUCTION GROUP D
CONTROL GROUP-NO EXTRA ANALGESIC ADDED GROUP C
ULTRASOUND GUIDED BILATERAL SUBCOSTAL TAP BLOCK WITH 20 ML OF 0.25% BUPIVACAINE GROUP B |
PERI-OPERATIVE MULTI MODAL ANALGESIA WITH ULTRASOUND GUIDED BILATERAL SUBCOSTAL TAP BLOCK FOR POST OPERATIVE ANALGESIA IN ELECTIVE LAPROSCOPIC CHOLECYSTECTOMY PATIENTS |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA-I & II
PTS UNDERGOING LAP CHOLECYSTECTOMY
UNDER GA
|
|
ExclusionCriteria |
Details |
1. H/0 ALLERGY TO TEST DRUGS
2.CONVERSION TO OPEN CHOLECYSTECTOMY
3 BRONCHIAL ASTHMA
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Adequate intraoperative and post operative analgesia achieved in laproscopic cholecystectomy patients |
total rescue analgesia asked in 24 hours.
first rescue analgesia asked within how many hours by each group. |
|
Secondary Outcome
|
Outcome |
TimePoints |
hemodynamic changes during intraoperative period of the surgery and post op rescue analgesia used. |
post op rescue analgesia asked ranges from within 1 hour to 8 hours after surgery |
|
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
|
N/A |
Date of First Enrollment (India)
|
07/01/2022 |
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="1" Months="6" Days="3" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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 (Others) -
- For how long will this data be available start date provided 23-10-2021 and end date provided 23-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Surgical
pain is a universal phenomenon affecting all patients perioperatively. Apart
from the agonizing sensory experience associated with it, acute pain has several
deleterious effects on the physiology and the psyche of the sufferer(3).An
anticipation of these effects combined with a humanitarian urge to relieve
pain, play a pivotal role in provision and optimization of postoperative
analgesia.
Laparoscopic
cholecystectomy is a minimally invasive procedure which is increasingly
performed as a day care procedure.
Though
minimally invasive, pain experienced following laparoscopic cholecystectomy in
the immediate postoperative period may vary from moderate to severe in intensity.
Pain
after laparoscopic cholecystectomy can be divided into three compartments;
visceral, parietal and referred shoulder pain.
The
main sources of pain include pain from incision sites(50-70%),pnemoperitoneum(20-30%),and
post cholecystectomy wound(10-20%) within the liver causing visceral pain. Postoperatively
common location of the pain is right upper quadrant and port sites.
The
main objective of treating the post-operative pain is to eradicate or, to
minimize the pain and to speed up the healing process without any side effects.
As
a part of multi-modal analgesia, various approaches are employed for achieving
safe and effective post operative analgesia. Clinical application of
conventional perioperative analgesic modalities(eg.opoids,epidural analgesia)was
limited because of their own drawbacks.
Transversusabdominis
plane block (TAP) that delivers local anaesthetic into transversusabdominis
plane has been shown to reduce perioperativeopoid use in elective abdominal
surgery,including open appendicectomy,laparoscopic cholecystectomies,caesarean
section and laparotomies.
The
use of point of care ultrasonography in abdominal blocks increases the success
rate and safety of the block .A variant of TAP block is (SCTAP)block where the
local anesthetic is deposited between the transverse abdominis plane inferior
and parallel to the costal margin. The
Subcostal transverses abdominis
plane block provides adequate analgesia for supraumbilical surgeries because of
its greater cranial spread(T6-T10).
MULTIMODAL
ANALGESIA-Is defined as the use of more than one pharmacological class of
analgesic medication targeting different receptors along the pain pathway with
the goal of improving analgesia while reducing individual side effects.(1)
Multi-modal
analgesia in the peri-operative period eliminates over reliance on opoids for
pain control and to reduce opoid related side effects.
Preemptive
multi-modal analgesia,combining non-opoid analgesics,Paracetamol,non
steroidalani-inflammatory drugs or coxib and local anaesthesia has a long
history. Local anesthesia improves postoperative pain and facilitates discharge
on the day of surgery(4).
Thus
the aim of the present study is to summarize the available best evidence and
well established practice for perioperative analgesia in elective laparoscopic
cholecystectomy.
|