FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076122 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 02/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Types of Pain Relief methods After Laparoscopic Abdominal Hysterectomy. 
Scientific Title of Study   Comparison of Transversalis Fascia Plane Block with Quadratus Lumborum Block for Postoperative Analgesia After Laparoscopic Abdominal Hysterectomy 
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 Anamika Kumari 
Designation  Junior Resident (MD ANAESTHESIA) 
Affiliation  TMU MEDICAL COLLEGE AND HOSPITAL MORADABAD 
Address  Room no 204 2nd floor Department of Anaesthesia Teerthanker Mahaveer Medical College and Research centre Moradabad Uttar Pradesh 244001 India

Moradabad
UTTAR PRADESH
244001
India 
Phone  8340555122  
Fax    
Email  anamikak307@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Kumar Prasad 
Designation  Professor and HOD 
Affiliation  Teerthanker Mahaveer Medical College and Research Centre,Moradabad,Uttar Pradesh 
Address  Room no 204 2nd floor Department of Anaesthesia Teerthanker Mahaveer Medical college and research centre Moradabad Uttar Pradesh 244001 India

Moradabad
UTTAR PRADESH
244001
India 
Phone  9837624543  
Fax    
Email  drmukeshprasad.medi@tmu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Payal Jain 
Designation  Associate Professor 
Affiliation  Teerthanker Mahaveer Medical College and Research Centre,Moradabad,Uttar Pradesh 
Address  Room no 204 2nd floor Department of Anaesthesia Teerthanker Mahaveer Medical college and research centre Moradabad Uttar Pradesh 244001 India

Moradabad
UTTAR PRADESH
244001
India 
Phone  9855567933  
Fax    
Email  payalravi1408@gmail.com  
 
Source of Monetary or Material Support  
Teerthanker Mahaveer Medical College and Research Centre,Moradabad, Uttar Pradesh 244001 
 
Primary Sponsor  
Name  Teerthanker Mahaveer Medical College and Research Centre 
Address  Teerthanker Mahaveer Medical College and Research Centre, N.H.-24,Delhi Road, Moradabad-244001, Uttar Pradesh 
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 
Dr Anamika Kumari  Teerthanker Mahaveer Medical College and Research Centre  Room no 4,Department of Anaesthesia Moradabad UTTAR PRADESH
Moradabad
UTTAR PRADESH 		 8340555122

anamikak307@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Teerthanker Mahaveer University-Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N70-N77||Inflammatory diseases of female pelvic organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quadratus lumborum block  25ml of 0.5% Ropivacaine in 5min,10min,15min,20min,25min and 30min 
Comparator Agent  Transversalis fascia plane block  25ml of 0.5% Ropivacaine in 5min,10min,15min,20min,25min and 30min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient posted for elective Laparoscopic Hysterectomy giving written and informed consent .
Age between 18 and 65 yrs.
American society of anesthesiologist (ASA) physical status I-II.
 
 
ExclusionCriteria 
Details  BMI more than 35kg/m2
history of coagulopathy
history of chronic opiate abuse/alchol abuse
pre existing chronic pain
allergy to LA
infection at injection site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare total consumption of analgesics in 24 hours postoperatively.  To compare total consumption of analgesics in 1hr,2hr,3hr subsquently every 1hr total 24hr duration 
 
Secondary Outcome  
Outcome  TimePoints 
To compare duration of first rescue analgesia.

To compare VAS(Visual Analogue scale) score of the patients.
To compare hemodynamic parameters of the patient. 		 Total rescue analgesic consumption in 24 hrs will be noted every hourly.
VAS score will be recorded at the end of surgery
immediately after block 30 mins, 45mins, 1hr, 2hr, 4hr, 8hr,then after 12hr, and 24hr

hemodynamic parameters will be recorded at the end of surgery
immediately after block 30 mins, 45mins, 1hr, 2hr, 4hr, 8hr,then after 12hr, and 24hr
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   18/11/2024 
Date of Study Completion (India) 31/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/03/2026 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
After getting approval from Institutional Ethical Committee (IEC) ,those patients who are fit in inclusion criteria will be included in our study.

Two groups both including 45 patients will be created and randomization will be done by computer method.

General Anaesthesia will be given as per the institution’s protocol.

•After Surgery before Extubation.
•Group QL-Quadratus lumborum  25ml of 0.5% Ropivacaine
•Group TF- Transversalis fascia plane block 25ml of 0.5% Ropivacaine.

The patient will be shifted to PACU and standard analgesia (1 gm PCM 8 hourly i/v) will be given as per standard institute protocol.
VAS score and hemodynamic parameters will be recorded at the end of surgery immediately after block 15mins, 30 mins, 45mins, 1hr, 2hr, 4hr, 8hr,then after 12hr, and 24hr

•VAS >4 will be given rescue analgesia in form of I/V Tramadol 1gm/kg body weight.
•Total rescue analgesic consumption in 24 hrs and complications will be noted.
•Data will be analyzed using the appropriate statistical method.

 
Close