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CTRI Number  CTRI/2025/11/096851 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Pain Relief Methods After Lower Abdominal Surgery: TAP Block And Epidural Block to find which provides better postoperative pain control 
Scientific Title of Study   Comparison of the efficacy and outcomes between ultrasound guided transversus abdominis plane TAP block and epidural block for postoperative analgesia in patients undergoing lower abdominal surgeries under spinal anesthesia 
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 Vinay Kumar Beniwal 
Designation  Resident Anesthesiology 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bhilo Ka Bedla Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  7703983067  
Fax    
Email  drvinaybeniwal82@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tasha Purohit 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bhilo Ka Bedla Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9587850617  
Fax    
Email  tashapurohit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tasha Purohit 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bhilo Ka Bedla Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9587850617  
Fax    
Email  tashapurohit@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bhilo Ka Bedla Udaipur Rajasthan pin code 313001 
 
Primary Sponsor  
Name  Pacific Medical College and Hospital Udaipur 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bhilo Ka Bedla Udaipur Rajasthan 313001 
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 Vinay Kumar Beniwal  Pacific Medical College and Hospital  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bhilo Ka Bedla Udaipur Rajasthan
Udaipur
RAJASTHAN 		 7703983067

drvinaybeniwal82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Pacific Medical College and Hospital Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G891||Acute pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Epidural Block  10ml of 0.125percent bupivacaine administered via epidural catheter at the end of surgery under spinal anesthesia Analgesic effect expected to last for approximately 18 to 24 hours postoperatively 
Intervention  Ultrasound guided transversus abdominis Plane block  20 ml of 0.25percent bupivacaine bilaterally administered under Ultrasound guidance at the transversus abdominis Plane following completion of surgery under spinal anesthesia Analgesic effect expected to last for approximately 12 to 18 hours postoperatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult patients aged between 18 and 60 years.
2. Patients of ASA grade I and II.
3. Patients undergoing elective lower abdominal surgeries under general anesthesia.
 
 
ExclusionCriteria 
Details  1. Patients not giving written and informed consent.
2. ASA grade III and above.
3. Pregnant patients.
4. Coagulation disorders and thrombocytopenia with a platelet count of less than 150,000
5. Infection at the site of injection and insertion of the needle 8.
6. Use of opioids or alpha-2 agonists for sedation, premedication, or postoperative analgesia except for tramadol.
7. Patients having cardiovascular abnormalities.
8. adverse reaction to local anesthetic.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of ultrasound-guided bilateral transversus abdominis plane(TAP) block as an analgesic technique compared to epidural analgesia and the time required for first rescue analgesia.   To evaluate the efficacy of ultrasound-guided bilateral transversus abdominis plane(TAP) block as an analgesic technique compared to epidural analgesia and the time required for first rescue analgesia assesments will be done at 1 2 4 and 6th hourly postoperatively  
 
Secondary Outcome  
Outcome  TimePoints 
1 To compare the postoperative analgesic requirements following transversus abdominis plane(TAP) block and epidural analgesia.
2 To compare the hemodynamic changes postoperatively between ultrasound-guided bilateral transversus abdominis plane(TAP) block and epidural analgesia.

 		 Measured from completion of block until first request for rescue analgesia; total rescue analgesic consumption recorded up to 24 hours postoperatively 0, 1, 2, 4, 6, 12, and 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/11/2025 
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="1"
Months="6"
Days="0" 
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   For patients undergoing lower abdominal surgeries under spinal anesthesia, epidural block offers superior and longer-lasting analgesia but comes with a higher incidence of side effects and longer recovery times. TAP block provides effective analgesia with fewer side effects,shorter recovery, and higher patient satisfaction, making it a suitable alternative, especially when epidural analgesia is contraindicated or not preferred. Ultimately, the choice between these techniques should be individualized based on patient factors, surgical considerations, and institutional resources.

 
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