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CTRI Number  CTRI/2020/11/029351 [Registered on: 25/11/2020] Trial Registered Prospectively
Last Modified On: 15/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   postoperative pain relief in lower abdominal surgery patients using either tranversis abdominis plane block or epidural analgesia 
Scientific Title of Study   comparative study of transverse abdominis plane block versus epidural analgesia in post operative pain management following lower abdominal surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shyjar babu j 
Designation  Junior Resident 
Affiliation  Azeezia Medical College 
Address  Department of Anesthesia Azeezia Medical College Kollam
Diamond hills Meeyanoor Kollam
Kollam
KERALA
691537
India 
Phone  9633841122  
Fax    
Email  shyjarbabu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shyjar babu J 
Designation  Junior Resident  
Affiliation  Azeezia Medical College 
Address  Department of Anesthesia Azeezia Medical College Kollam
Diamond Hills Meeyanoor Kollam
Kollam
KERALA
691537
India 
Phone  9633841122  
Fax    
Email  shyjarbabu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr George K George 
Designation  Professor and HOD 
Affiliation  Azeezia Medical College  
Address  Department of Anesthesia Azeezia Medical College Kollam
Diamond hills Meeyanoor Kollam
Kollam
KERALA
691537
India 
Phone  8921762254  
Fax    
Email  drgeorgekg@gmail.com  
 
Source of Monetary or Material Support  
azeezia medical college kollam 
 
Primary Sponsor  
Name  Azeezia Medical College 
Address  Diamond Hills Meeyanoor Kollam 
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 Shyjar babu J  Azeezia Medical Collage , Kollam  OT complex Department of anesthesia
Kollam
KERALA 
9633841122

shyjarbabu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
azeezia ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  epidural analgesia  administering local analgesic in epidural space with 0.25 % bupivacaine 0.3 ml/kg for postoperative pain relief  
Intervention  transversis abdominus plane block  administering local anestehtic to transversis abdominis plane with 0.125 % bupivacaine 0.5 ml/kg for postoperative analgesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult patients ASA 1 and ASA 2 undergoing lower
abdominal surgeries under general anaesthesia
 
 
ExclusionCriteria 
Details  1. Refusal to consent
2. Contraindication to TAP block and epidural analgesia such as
a) soft-tissue infection of the abdominal wall and skin;
b) patients suffering from coagulopathy
c) those requiring postoperative mechanical ventilation;
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
post operative pain relief  3rd 6th and 9th hour postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
rescue analgesia consumption  3rd 6th and 9 th hour postoperatively 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   15/12/2020 
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   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Postoperative pain control after surgery is one of the basic medical issues and challenges. Most patients who had undergone surgical procedures experience acute postoperative pain, but evidence suggests that less than half of them report adequate postoperative pain relief. Routinely the opioids are used for pain control after surgery; however, the widespread use of opioids has numerous side effects and delay postoperative recovery.  According to the World Health Organization guidelines, the excessive use of opioids decreases the patients’ satisfaction.

              Epidural analgesia is considered to be the most effective method of pain relief and is often the preferred choice of analgesia. In search a regional technique for effective post-operative analgesia transverse abdominis plane block provide post-operative analgesia with decreased systemic effect. It is relatively simple and efficacious. It has been reported to significantly reduce pain associated with lower abdominal surgery, regardless of whether it is used as the primary anaesthetic or for pain control after general anaesthesia . Tap block along with reduction in postoperative pain, it also decreases analgesic drug usage.

 
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