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CTRI Number  CTRI/2024/05/067299 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 13/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Pain Relief After Surgery: Side Muscle Block vs. Abdominal Wall Block in patients undergoing Gallbladder Removal 
Scientific Title of Study   Comparison of duration of postoperative analgesia after lateral quadratus lumborum block versus subcostal transversus abdominis plane block in laparoscopic cholecystectomy- A randomised controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Riya Ravindran 
Designation  Postgraduate resident 
Affiliation  Bangalore Medical College and Research Institute 
Address  2nd floor, Block B, Departmet of Anaesthesiology Bangalore Medical College and Research Institute KR Road,Fort,Bangalore-560002

Bangalore
KARNATAKA
560002
India 
Phone  08884342540  
Fax    
Email  riyaravindran4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saraswathi N 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  2nd floor, Block B, Department of Anaesthesiology Bangalore Medical College and Research Institute,Bangalore Fort,K R Road Bangalore-560002

Bangalore
KARNATAKA
560002
India 
Phone  9663304834  
Fax    
Email  dr.saraswathi.pmssy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saraswathi N 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  2nd floor,B block,Department of Anaesthesiology, Bangalore Medical College and Research Institute, Bangalore Fort, K R Road Bangalore-560002

Bangalore
KARNATAKA
560002
India 
Phone  9663304834  
Fax    
Email  dr.saraswathi.pmssy@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute, KR Road,Fort,Bangalore, Karnataka, India-560002 
 
Primary Sponsor  
Name  Bangalore Medical College and Research Institute 
Address  Bangalore Medical College and Research Institute,KR Road ,Fort, Bangalore -560002 
Type of Sponsor  Government 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 
Dr Riya Ravindran  Bangalore Medical College and Research Institute  Department of Anaesthesiology, 2nd floor, Block B, BMCRI,Bangalore Fort,K R Road Bangalore-560002
Bangalore
KARNATAKA 
08884342540

riyaravindran4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided lateral quadratus lumborum block   Lateral quadratus lumborum block given under ultrasound guidance with 0.25% Levobupivacaine with Dexamethasone 8mg bilaterally once after the surgery, before extubation for postoperative analgesia in laparoscopic cholecystectomy 
Comparator Agent  Ultrasound guided subcostal transversus abdominis plane block   Subcostal transversus abdominis plane block given under ultrasound guidance with 0.25% Levobupivacaine with Dexamethasone 8mg bilaterally ,once after the surgery before extubation for postoperative analgesia in laparoscopic cholecystectomy  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who are willing to give informed consent.
Patients of age 18-60 years.
ASA grade 1 & 2.
Patients with BMI 18.5-25.
Patients undergoing laparoscopic cholecystectomy.
 
 
ExclusionCriteria 
Details  Patient refusal.
Patients with history of coagulopathy.
Patients with history of allergic to local anaesthetic.
Patients with severe systemic diseases.
Psychiatric illness.
Chronic medication taking for pain.
Patient requiring postoperative mechanical ventilation.
Localized infection over injection point.
Duration of surgery more than 3 hours.
 
 
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 
To assess postoperative analgesia using VAS score  To assess VAS score at 30 minutes, 60minutes, 1hour, 2hour, 4hour,8hour,12hour,24hour postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Need of rescue analgesia  Time of requirement of first dose od Inj.Tramadol 2mg per kg body weight 
Hemodynamic parameters like Heart rate, blood pressue and spO2  Assess heart rate, blood pressure, spO2 at 30 minutes, 60minutes, 1hour, 2hour, 4hour,8hour,12hour,24hour postoperatively 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   03/06/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Laparoscopic surgery is nowadays a common technique used in variety of abdominal surgeries including cholecystectomy, appendicectomy, inguinal hernia repair, hemicolectomy etc. Eventhough post-operative pain after laparoscopy is lesser than in open operative techniques, the abdomen stiffness due to the pneumoperitoneum (created as a step of the laparoscopic approach) and operative manipulations  may cause severe postoperative pain that will affect the patient satisfaction and the outcome of the surgery.1

The various modes of pain management include parenteral administration of opioids, NSAIDs, wound infiltration with local anaesthetics, neuraxial anaesthesia, peripheral nerve blocks.etc. Multimodal approach provide better pain control. But these techniques are associated with drawbacks- opioids are associated with vomiting, pruritus, oversedation and respiratory depression;NSAIDs  can cause nausea, vomiting and gastric irritation,etc. Regional anesthesia techniques can be used as sole anesthetic technique or adjuvant to general anesthesia for intra  operative and postoperative analgesia.2

The transversus abdominis plane (TAP)block, first introduced by Rafi in 2001 as a landmark-guided technique via the triangle of Petit to achieve a field block. It involves the injection of a local anesthetic solution into the plane between the internal oblique muscle and transversus abdominis muscle.The local anesthetic spread in this plane can block the neural afferents and provide analgesia to the anterolateral abdominal wall, as the thoracolumbar nerves originating from the T6 to L1 spinal roots run into this plane and supply sensory nerves to the anterolateral abdominal wall.3USG facilitates accurate placement of block needle and real time deposition of local anaesthetic, increasing both margin of safety and block quality.4

Quadratus lumborum block is a block of the posterior abdominal wall, “interfascial plane block” which is performed under ultrasound guidance. It was described by anaesthesiologist Dr. Rafael Blanco as a variant of TAP block in 2007.Today four types of QL block are performed which differ by the site of drug application. These are QLB1or lateral QLB, QLB2 or posterior QLB, QLB3 or anterior /transmuscular QLB and QLB4 or intramuscular QLB. QLB1 or lateral QLB implies the application of local anaesthetics on the lateral side of the QLM on the area of its contact with transverasalis fascia, at the level where tranversus abdominis muscle taper off to its aponeurosis.5

This study is aimed to compare and evaluate the analgesic effectiveness between Lateral QLB and  subcostal TAPB after laparoscopic cholecystectomy.

 
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