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CTRI Number  CTRI/2023/06/053597 [Registered on: 06/06/2023] Trial Registered Prospectively
Last Modified On: 05/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of nerves block in female patients 
Scientific Title of Study   A comparison between modified thoracoabdominal nerves block through perichondrial approach versus laparoscopic assisted transversus abdominis plane block for quality of recovery in patients undergoing gynaecological laparoscopic surgery: A Prospective Randomized Control Trials 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  T Revanth prasad 
Designation  Junior resident 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna,Bihar.
Sheikhpura,Patna,Bihar
Patna
BIHAR
800014
India 
Phone  9441116915  
Fax    
Email  revanthprasad131@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna,Bihar
Sheikhpura,Patna,Bihar
Patna
BIHAR
800014
India 
Phone  8544413241  
Fax    
Email  swatipgi2006@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swati 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna,Bihar
Sheikhpura,Patna,Bihar
Patna
BIHAR
800014
India 
Phone  8544413241  
Fax    
Email  swatipgi2006@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi institute of Medical sciences,Patna 
 
Primary Sponsor  
Name  T Revanth Prasad 
Address  Department of Anaesthesiology and CCM 1st floor,OT complex, Indira Gandhi institute of Medical sciences,[IGIMS],Patna  
Type of Sponsor  Other [[self]] 
 
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 
T Revanth prasad  Indira Gandhi Institute of Medical Sciences  Department of Anaesthesiology and CCM, 1st floor, OT complex
Patna
BIHAR 		 9441116915

revanthprasad131@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  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 
Comparator Agent  Laparoscopic assisted transversus abdominis plane[TAP] block  In this block,for patients with disease [fibroids and endometriosis] undergoing gynaecological laparoscopic surgery,20-25 ml of 0.25% of bupivacaine with epinephrine given during end of surgery. 
Intervention  Modified Thoraco abdominal nerves block through perichondrial approach  In this block, patients with disease [fibroids and endometriosis] undergoing gynaecological laparoscopic surgery,25ml of 0.25% ropivacaine given during end of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1.Age between 18 and 5O years
2.American society of Anesthesiologists [ASA]
physical status I to III
3.Body mass index between 18 and 35 kg/m2
4.Undergoing gyanecological [fibroid/endometriosis]
laparoscopic surgery 
 
ExclusionCriteria 
Details  1.Inability to consent to the study
2.Coagulopathy
3.Sepsis
4.Hepatic or Renal failure
5.Allergy to local anesthetic [LA]
6.Opioid intake at home 
 
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 
Quality of recovery assessed using the Quality of recovery-15 [QoR-15] scale   All parameters will be recorded 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1.Static [at rest] & dynamic
[with movement] pain scores
and [Numeric rating scale
score 1-10]
2.Performance time
[the temporal interval
between the start of skin
disinfection and the end of
Local anesthetic injection
through the block needle]
3.The block related adverse
events [ vascular puncture,
paresthesia,local anesthetic
toxicity]

 		 All parameters recorded post operatively at 3,6,12,24 hours 
 
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   Phase 4 
Date of First Enrollment (India)   19/06/2023 
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   Plan to publish after thesis completion 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   We will evalaute the postoperative pain relief using two different techniques for laparoscopic gynaecological surgeries. The MTAPA block will be given in one group and laparoscopic assisted TAP block will be given to the other group. The primary outcome of the study will be Quality of recovery score -15 (QoR-15) at 24 hour postoperatively. 
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