FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/085311 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Role of transversus abdominis plane block with ultrasound using different drugs in addition for prolonging the pain relief after total abdominal hysterectomy 
Scientific Title of Study   Role of USG guided transversus abdominis plane block with different adjuvants in enhancing postoperative analgesia in total 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  Thupili Poshitha Sai 
Designation  Post graduate 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE 
Address  Department of Anesthesiology, First floor major ot complex, Dr.B.R.Ambedkar medical college and hospital, K.G halli,Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  09949941347  
Fax    
Email  poshithasai1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reshma B M 
Designation  Associate Professor 
Affiliation  DR B R Ambedkar medical college 
Address  Department of Anesthesiology,Dr BR Ambedkar medical college and hospital,Shampura main road,K G Halli,Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8892019120  
Fax    
Email  lucky3276@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reshma B M 
Designation  Associate Professor 
Affiliation  DR B R Ambedkar Medical College 
Address  Department of Anesthesiology BR Ambedkar medical college and Hospital, Shampura main road, K G Halli, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8892019120  
Fax    
Email  lucky3276@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar Medical College 
 
Primary Sponsor  
Name  Department of Anesthesiology 
Address  Dr B R Ambedkar medical college and hospital,Shampura main road,K G Halli,Bangalore,560045 
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 RESHMA B M  DR B R AMBEDKAR MEDICAL COLLEGE  FIRST FLOOR OT COMPLEX DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SHAMPURA MAIN ROAD K G HALLI BANGALORE
Bangalore
KARNATAKA 		 08892019120

lucky3276@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N800||Endometriosis of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  usg guided transversus abdominis plane block with dexmedetomidine as adjuvant  usg guided transversus abdominis plane block with 0.2 % ropivacaine with dexmedtomidine 0.5mcg/kg 
Intervention  usg guided transversus abdominis plane block with ropivacaine  usg guided transversus abdominis plane block with 0.2% ropivacaine 
Comparator Agent  usg guided transversus abdominis plane block with ropivacaine and dexamethasone  usg guided transversus abdominis plane block with 0.2% ropivacaine and dexamethasone 4mg 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  patients of ASA-1 and 2 undergoing total abdominal hysterectomy under spinal anesthesia 
 
ExclusionCriteria 
Details  1. Patient refusal to participate in the study
2. Infection at the block site.
3. Neurological deficit in lower limbs.
4. Altered coagulation status
5. Patients with heart blocks
6. Patients taking analgesics for other reasons 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the duration of postoperative analgesia and requirement of first
rescue analgesic.  		 till 24 hours post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the cumulative consumption of additional analgesia in 12 and
24 hours in both the groups.
 		 till 24 hours post-surgery 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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 2/ Phase 3 
Date of First Enrollment (India)   28/04/2025 
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="0"
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   Abdominal hysterectomy is open surgical procedure associated with considerable post operative pain. The use of transverse lower abdominal incisions in hysterectomies and myomectomies often cause severe pain during first 48 hours postoperatively which can adversely impact healing, patient outcomes and prolong the length of hospital stay .More recently multimodal analgesia like tap blocks has been providing better post operative pain relief. Ropivacaine is an amide local anesthetic with better sensory and motor blocking profiles and with low toxicity potential. Dexmedetomidine  is an selective alpha 2 adrenergic agonist with sedative and analgesic properties. Dexamethasone as an adjuvant causes early onset and prolongs the duration of analgesia. Thus in our current study we aim to assess the efficacy of 0.25 ropivacaine and compare it with dexamethasone and dexmedetomidine in USG guided TAP block in providing post operative analgesia. 
Close