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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  
VIMS and RC 
 
Primary Sponsor  
Name  VIMS and RC 
Address  Vydehi Institute of medical sciences 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. 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.

  7. 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.

 

 
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