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CTRI Number  CTRI/2024/08/073157 [Registered on: 30/08/2024] Trial Registered Prospectively
Last Modified On: 30/08/2024
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   comparison for quality of post op analgesia between modified thoracoabdominal plane nerve block through perichondrial approach and subcostal transversus abdominis plane block in laparoscopic cholecystectomy patients  
Scientific Title of Study   comparison of modified thoracoabdominal plane nerve block through perichondrial approach and subcostal transversus abdomens plane block for quality of post operative analgesia in patients undergoing laparoscopic cholecystectomy a randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sania 
Designation  Post graduate resident 
Affiliation  lady hardinge medical college and associated hospitals 
Address  Anesthesia Department New Academic Block Floor 5 Lady Hardinge Medical College and Its Associated Hospitals Bangla sahib road New delhi 110001

Central
DELHI
110001
India 
Phone  07009961544  
Fax    
Email  saniaduggar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Kumar 
Designation  Professor  
Affiliation  lady hardinge medical college and associated hospitals 
Address  Anesthesia Department New Academic Block Floor 5 Lady Hardinge Medical College and Its Associated Hospitals Bangla sahib road New delhi 110001

Central
DELHI
110001
India 
Phone  8084660100  
Fax    
Email  drkumaranil@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil kumar 
Designation  Proffessor 
Affiliation  lady hardinge medical college and associated hospitals 
Address  Anesthesia Department New Academic Block Floor 5 Lady Hardinge Medical College and Its Associated Hospitals Bangla sahib road New delhi 110001

Central
DELHI
110001
India 
Phone  8084660100  
Fax    
Email  drkumaranil@yahoo.com  
 
Source of Monetary or Material Support  
Anaesthesia department, Lady hardinge medical college and associated hospitals near Bangla sahib road Connaught Place New Delhi 110001 
 
Primary Sponsor  
Name  Lady hardinge medical college and associated hospitals 
Address  Anesthesia Department New Academic Block Floor 5 Lady Hardinge Medical College and Its Associated Hospitals Bangla sahib road New delhi 110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 
Doctor Sania  Lady Hardinge Medical College And Associated Hospitals  anaesthesia department Lady hardinge medical college and associated hospitals Connaught place Bangla Sahib New Delhi 110001
Central
DELHI 
07009961544

saniaduggar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for human research LHMC and associated hospitals,New Delhi   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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modified thoracoabdominal nerve block through perichondrial approach  Following the tracheal intubation, for Group M-TAPA, a high-frequency linear probe (6–13 MHz Sonosite M Turbo® Machine) will be placed in the sagittal direction on the 10th costal margin under the guidance of USG to define the transversus abdominis, internal oblique, and external oblique muscles. Thereafter a deep angle will be given to the costochondral angle to visualise the plane between costal cartilage and transversus abdominis muscle. By using the in-plane technique, a 22G, 100 mm block needle (Stimuplex B-Braun Medical, Melsungen, Germany) will be placed in the cranial direction between the transversus abdominis muscle and the lower surface of the costal cartilage by moving the needle tip towards the posterior aspect of the 10th costal cartilage. Then, 20 ml of 0.25% bupivacaine will be injected into the lower surface of the costal cartilage making sure that the needle tip will not cross the cranial edge of the 10th costal cartilage. The same process will then be repeated for the other side.  
Comparator Agent  TAP TECHNIQUE-SUBCOSTAL TRANVERSUS ABDOMINAL BLOCK  The ultrasound probe (6–13 MHz Sonosite M Turbo® Machine) will be placed in the midline of the abdomen 2 cm below the xiphisternum and moved right laterally along the subcostal margin to the anterior axillary line to locate the space between the transversus abdominis muscle lying beneath and extending lateral to the rectus abdominis muscle. A 100-mm, 22-G Stimuplex block needle will then be guided, in plane, such that the tip will lie between the transversus abdominis and rectus abdominis fascial plane. The same process will then be repeated for the other side 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists (ASA) classes I–II patients
Patients 18 yrs to 65yrs of age
Planned for laparoscopic cholecystectomy of either sex under general anaesthesia 
 
ExclusionCriteria 
Details  ASA III-IV patients
Any known drug allergies
Contraindication to nerve block like coagulopathy bleeding diathesis and local infections
Not giving the consent for the block
Inability to understand or use the numerical rating scale and QOR 15 score
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Median numeric pain rating score NRS in first 24 hours post operatively between thoracoabdominal nerve block and subcostal transversus abdominis block groups .  At 0 min 15 min 30 min 1 hour 3 hour 6 hour 12 hour 24hours postoperative  
 
Secondary Outcome  
Outcome  TimePoints 
1Mean dose in mg opioid consumption in morphine equivalent mgperkg in first 24 hours postoperatively
2 Mean duration of analgesia in minutes
3 Total number of skin puncture to perform the block
4 Mean duration taken in minutes for completion of block
5 Proportion of patients developing complications related to block
6 Mean of QOR 15 score 
1 First 24 hours postoperative
2 Time of first analgesic
3 At the end of successful block( will be noted in minutes)
4 At the end of successful block( will be noted in minutes)
5postoperative
6 postoperative  
 
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   Phase 4 
Date of First Enrollment (India)   10/09/2024 
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="1"
Days="25" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Now a days laparoscopic cholecystectomy is a procedure of choice in surgical treatment for
symptomatic cholelithiasis Recovery after laparoscopic cholecystectomy depends upon
several factors Such as abdominal pain nausea vomiting and fatigue Although post
operative pain after laparoscopic cholecystectomy mainly depends upon factors like
peritoneal stretching and diaphragmatic irritation caused by high intraabdominal pressure and
by carbon dioxide retention Nonetheless total abdominal pain following laparoscopic
cholecystectomy is having somatic and visceral components Therefore our aim should be
to reduce the somatic component of pain that is incisional pain after laparoscopic
cholecystectomy It has also been stated that laparoscopic cholecystectomy causes significant
postoperative pain in one third of post operative patients up to first 24 hours after surgery A
recent PROSPECT review reported that standard way to reduce postoperative pain after
laparoscopic cholecystectomy is preoperative or intraoperative use of paracetamol with
NSAID and port site Local anaesthetic infiltration with long acting local anaesthetic agent
and also suggests that there is no role of number of surgical port insertion recently
published review and meta-analysis suggest that subcostal transversus abdominis plane
TAP block is having greatest reduction in pain score at 12 hours postoperatively compared
with other regional analgesic techniques
Subcostal TAP block was first suggested by Hebbard et al. and it is proven to provide
adequate analgesia for upper and lower abdominal surgeries  However, pain from the
incision site for the right lateral port in the laparoscopic cholecystectomy may not be
covered because it cannot block the lateral cutaneous branches of the thoracoabdominal
nerves To compensate this shortcomings of subcostal TAP block, Tulgar et al. introduced a
newer regional analgesic technique called as modified thoracoabdominal nerve block
through the perichondral approach  M TAPA in 2019  In this technique local anesthetics
are administered only to the underside of the perichondrial surface of tenth rib It has been
found that this technique provides a sensory block between T5-T12 dermatomes This has
recently been used for postoperative analgesia in laparoscopic abdominal surgeries because it
is considered to provide effective analgesia in the anterior and lateral thoracoabdominal
wallsThere are limited literature comparing the efficacy of modified  thoracoabdominal nerve blocks TAPA with
 subcostal  transversus abdominis plane blocks STAP therefore further studies are required to conclude the efficacy between the two fascial plane block

 
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