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CTRI Number  CTRI/2020/07/026739 [Registered on: 22/07/2020] Trial Registered Prospectively
Last Modified On: 16/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “The efficacy of Ultrasound guided Transversus Abdominis Plane Block versus Quadratus Lumborum in Patients Undergoing Lower Abdominal surgeries: A Prospective Randomized Controlled Study" 
Scientific Title of Study   “The efficacy of Ultrasound guided Transversus Abdominis Plane Block versus Quadratus Lumborum block for post operative analgesia in Patients Undergoing Lower Abdominal surgeries: A Prospective Randomized Controlled Study" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Roshni benedicta 
Designation  post graduate 
Affiliation  Rajiv Gandhi university of health sciences bangalore 
Address  Department of Anesthesiology 2nd floor Operation theater complex St Johns medical college
Department of Anesthesiology St Johns medical college
Bangalore
KARNATAKA
Bengaluru, 560034
India 
Phone  9916710067  
Fax    
Email  viji.roshni94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lagoo Jui Yeshawant 
Designation  assosiate professor 
Affiliation  St. Johns medical college 
Address  Department of Anesthesiology St Johns medical college
Department of Anesthesiology St Johns medical college
Bangalore
KARNATAKA
Bengaluru, 560034
India 
Phone  9916710067  
Fax    
Email  geetjui@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Roshni benedicta 
Designation  post graduate 
Affiliation  St. Johns medical college 
Address  Department of Anesthesiology St Johns medical college
Department of Anesthesiology St Johns medical college

KARNATAKA
Bengaluru, 560034
India 
Phone  9916710067  
Fax    
Email  viji.roshni94@gmail.com  
 
Source of Monetary or Material Support  
Ultrasound guided nerve block in post operative analgesia is the standard of care in our institution St. Johns medical college, Bengaluru, Karnataka 
 
Primary Sponsor  
Name  Dr Roshni Benedicta 
Address  Department of anesthesiology, St. Johns medical college Bangalore  
Type of Sponsor  Other [principal investigator] 
 
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 Roshni Benedicta   st Johns medical college  OT Complex, Department of Anaesthesiology, st Johns medical college
Bangalore
KARNATAKA 
9916710067

viji.roshni94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- St. Johns medcial college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Transversus Abdominis Plane Block versus Quadratus Lumborum in Patients Undergoing Lower Abdominal surgeries  Patients will be randomly allocated to one of the two groups using computerized randomization technique. GROUP A: With the patient in supine position under strict aseptic precautions, TAP block will be performed under ultrasound guidance, the transducer will be positioned between the iliac crest and costal margin. The external oblique, internal oblique and transversus abdominis muscles will be identified. After identifying the TAP, the needle will be guided through the subcutaneous tissue, external oblique, and internal oblique. When the needle reaches the plane between the internal oblique and the transversus abdominis, after feeling a ‘pop’ 20ml of 0.125% bupivacaine + 4mg dexamethasone will be injected into this plane. The procedure will be repeated on the other side. GROUP B: In QL block, a linear transducer will be positioned between the iliac crest and costal margin in the midaxillary line and moved posteriorly so that the posterior aponeurosis of the transversus abdominis muscle is visible. The needle will be targeted deep to the aponeurosis and superficial to the transversalis fascia, at the lateral margin of QL muscle and 20ml of 0.125% bupivacaine + 4mg dexamethasone will be injected into this plane. The same procedure will be repeated on the other side for all patients.  
Intervention  Ultrasound guided Transversus Abdominis Plane Block ; Quadratus Lumborum in Patients Undergoing Lower Abdominal surgeries  patients will be randomly allocated into group A and B GROUP A: With the patient in supine position under strict aseptic precautions, TAP block will be performed under ultrasound guidance, the transducer will be positioned between the iliac crest and costal margin. The external oblique, internal oblique and transversus abdominis muscles will be identified. After identifying the TAP, the needle will be guided through the subcutaneous tissue, external oblique, and internal oblique. When the needle reaches the plane between the internal oblique and the transversus abdominis, after feeling a ‘pop’ 20ml of 0.125% bupivacaine + 4mg dexamethasone will be injected into this plane. The procedure will be repeated on the other side. GROUP B: In QL block, a linear transducer will be positioned between the iliac crest and costal margin in the midaxillary line and moved posteriorly so that the posterior aponeurosis of the transversus abdominis muscle is visible. The needle will be targeted deep to the aponeurosis and superficial to the transversalis fascia, at the lateral margin of QL muscle and 20ml of 20ml of 0.125% bupivacaine + 4mg dexamethasone will be injected into this plane. The same procedure will be repeated on the other side for all patients.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Adult patients in the age group of 20-59 years(ASA I-II) scheduled for various lower abdominal surgeries under subarachnoid block 
 
ExclusionCriteria 
Details  1.Known history of hypersensitivity to drugs used
2.History of significant cardiac, respiratory, renal, hepatic or central nervous system diseases
3.Infection at the site of the block
4.History of coagulopathy or anticoagulant medication intake
•Patients on chemotherapy & radiation therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To compare the efficacy of USG-guided bilateral QL block versus bilateral USG -guided TAP block for postoperative analgesia in patients undergoing various lower abdominal surgeries using the Numeric Pain Intensity Scale (NPIS)
2.To compare the time to rescue analgesia

SECONDARY
1.To compare the adverse outcomes of both the procedures
2.to evaluate patient satisfaction
 
All patients will be monitored at 0,1, 4, 8, 12 and 24 hours for the above-mentioned parameters. Patients will be asked to rate the pain they experience on a visual analogue scale (NPIS) from zero to ten, 0 being ‘no pain’ and 10 being ‘very severe pain’, time for first rescue dose of intravenous pethidine 0.5mg/kg body weight will be noted in both the groups and subsequent number of doses required over 24 hours will also be noted. 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY
To compare the adverse outcomes of both the procedures
To evaluate patient satisfaction
 
All patients will be monitored at 0,1, 4, 8, 12 and 24 hours for the above-mentioned parameters. Patients will be asked to rate the pain they experience on a visual analogue scale (NPIS) from zero to ten, 0 being ‘no pain’ and 10 being ‘very severe pain’, time for first rescue dose of intravenous pethidine 0.5mg/kg body weight will be noted in both the groups and subsequent number of doses required over 24 hours will also be noted. 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   10/09/2020 
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 Applicable 
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)?  

Brief Summary  

METHODOLOGY

After obtaining clearance from the institutional ethics committee and CTRI , 56 patients aged between 20- 59 years posted for lower abdominal surgeries will be included in the study. Patients will be randomly allocated into two groups (group A and B) using computerized randomization  technique.  Written informed consent will be taken from all the patients. Standard anesthesia monitors ECG, HR, NIBP, SPO2 will be connected. Intravenous access will be secured with 18G. The patients will be given spinal anaesthesia according to standard protocol, once the surgery is over and the level regresses to T12, ultrasound guided TAP block or QL block will be given under aseptic precautions. Ultrasound guided TAP block will be given for patients belonging to group A and QL block will be given to group B.

 

In patients belonging to group A ultrasound guided TAP block will be performed in the triangle of Petit. The triangle is bounded by the external oblique anteriorly, the latissimus dorsi posteriorly and the iliac crest inferiorly. The floor of the triangle, from superficial to deep is composed of subcutaneous tissue, and the fascial borders of external oblique, the internal oblique and the transversus abdominis muscles respectively. The iliac crest will be taken as a fixed landmark. A linear transducer will be positioned in the mid axillary line in this triangle, between the iliac crest and the costal margin. Under SAP, a needle will be introduced anteriorly, in plane under real-time ultrasound guidance to lie in the fascial planes between the internal oblique and transversus abdominis muscle. The position of the needle will be confirmed following which 20ml of 0.125% bupivacaine + 4mg dexamethasone will be injected on each side after aspiration. Spindle-shaped echo lucent shadow in the space between the two muscles would confirm a successful injection.

 

In patients belonging to group B, type 1 QL block will be performed. For the type 1 QL block, a linear transducer will be placed in the axial plane in the midaxillary line and moved posteriorly until the posterior aponeurosis of the transversus abdominis muscle becomes visible. The needle will be inserted from either the anterior or the posterior end of the transducer and advanced until the needle tip penetrates the posterior aponeurosis of the transversus abdominis muscle. The position of the needle will be confirmed following which 20ml of 0.125% bupivacaine + 4mg dexamethasone will be injected on each side after aspiration. Spindle-shaped echo lucent shadow in the space between the two muscles would confirm a successful injection

 

All patients would receive analgesics according to institutional multimodal analgesia protocol. The patients after receiving block will be monitored for the need for first rescue dose of intravenous pethidine 0.5mg/kg body weight and subsequent doses required over 24 hours. All patients will be monitored in the recovery room for 30 min after the procedure for parameters like heart rate, blood pressure, respiratory rate, SpO2, NPIS score and for loss of pain and temperature sensations at 0, 30 minutes and 1 hour in the dermatomal areas corresponding to the anterior abdominal wall. The patients will be shifted to surgical ward for postoperative monitoring. All patients will be monitored at 0,1, 4,  8, 12 and 24 hours for the above-mentioned parameters. Patients will be asked to rate the pain they experience on a visual analogue scale (NPIS) from zero to ten, 0 being ‘no pain’ and 10 being ‘very severe pain’, time for first rescue dose of intravenous pethidine 0.5mg/kg body weight will be noted in both the groups and subsequent number of doses required over 24 hours will also be noted. Any complications arising as a result of TAP block or QL block will be recorded. The results will be compared and tabulated on a excel sheet and analysed using SPSS software.

 

 

 

 

 

 
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